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Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

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ClinicalTrials.gov Identifier: NCT00873093
Recruitment Status : Completed
First Posted : April 1, 2009
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions B-cell Adult Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Lymphoblastic Lymphoma
T-cell Adult Acute Lymphoblastic Leukemia
T-cell Childhood Acute Lymphoblastic Leukemia
Interventions Drug: L-asparaginase
Drug: doxorubicin hydrochloride
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Drug: cytarabine
Drug: prednisone
Drug: bortezomib
Drug: pegaspargase
Drug: methotrexate
Drug: etoposide phosphate
Drug: cyclophosphamide
Biological: filgrastim
Drug: leucovorin calcium
Other: laboratory biomarker analysis
Drug: High Dose MTX
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Period Title: Overall Study
Started 4 62 49 23 10
Completed 3 35 33 12 8
Not Completed 1 27 16 11 2
Reason Not Completed
Adverse Event             0             2             0             0             0
Death             0             3             2             0             0
Physician Decision             0             17             10             10             2
Withdrawal by Subject             1             4             4             0             0
Ineligible             0             1             0             1             0
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy) Total
Hide Arm/Group Description Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Total of all reporting groups
Overall Number of Baseline Participants 4 62 49 23 10 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 62 participants 49 participants 23 participants 10 participants 148 participants
<=18 years
0
   0.0%
53
  85.5%
45
  91.8%
20
  87.0%
8
  80.0%
126
  85.1%
Between 18 and 65 years
4
 100.0%
9
  14.5%
4
   8.2%
3
  13.0%
2
  20.0%
22
  14.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 62 participants 49 participants 23 participants 10 participants 148 participants
23.14  (0.57) 10.16  (5.77) 9.27  (6.06) 13.00  (5.28) 13.79  (6.27) 10.91  (6.23)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 62 participants 49 participants 23 participants 10 participants 148 participants
Female
2
  50.0%
29
  46.8%
21
  42.9%
6
  26.1%
5
  50.0%
63
  42.6%
Male
2
  50.0%
33
  53.2%
28
  57.1%
17
  73.9%
5
  50.0%
85
  57.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 62 participants 49 participants 23 participants 10 participants 148 participants
Hispanic or Latino
1
  25.0%
15
  24.2%
18
  36.7%
4
  17.4%
0
   0.0%
38
  25.7%
Not Hispanic or Latino
3
  75.0%
44
  71.0%
31
  63.3%
19
  82.6%
10
 100.0%
107
  72.3%
Unknown or Not Reported
0
   0.0%
3
   4.8%
0
   0.0%
0
   0.0%
0
   0.0%
3
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 62 participants 49 participants 23 participants 10 participants 148 participants
American Indian or Alaska Native
0
   0.0%
1
   1.6%
1
   2.0%
1
   4.3%
0
   0.0%
3
   2.0%
Asian
0
   0.0%
3
   4.8%
1
   2.0%
1
   4.3%
0
   0.0%
5
   3.4%
Native Hawaiian or Other Pacific Islander
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
2
   1.4%
Black or African American
0
   0.0%
9
  14.5%
8
  16.3%
4
  17.4%
1
  10.0%
22
  14.9%
White
2
  50.0%
44
  71.0%
34
  69.4%
16
  69.6%
8
  80.0%
104
  70.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  25.0%
5
   8.1%
5
  10.2%
1
   4.3%
0
   0.0%
12
   8.1%
1.Primary Outcome
Title Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy
Hide Description The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.
Time Frame The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1.
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description:
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Overall Number of Participants Analyzed 0 54 46 0 0
Measure Type: Number
Unit of Measure: Percentage of participants
72.2 63
2.Primary Outcome
Title Event Free Survival
Hide Description Percentage of patients who were event free at 4 months
Time Frame 4 months after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis on this primary outcome is limited to pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) per protocol section 9.2.1.
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description:
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Overall Number of Participants Analyzed 0 54 46 0 0
Measure Type: Number
Unit of Measure: Percentage of participants
68.5 37.8
3.Primary Outcome
Title Toxic Death Rate
Hide Description The proportion of toxic death rate among all eligible patients.
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.
Arm/Group Title Overall
Hide Arm/Group Description:
All enrolled eligible patients.
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
2.1
4.Primary Outcome
Title Severe Adverse Events (SAE) Rate.
Hide Description The proportion of SAE rate among all eligible patients
Time Frame 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.
Arm/Group Title Overall
Hide Arm/Group Description:
All enrolled eligible patients.
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
8.2
5.Secondary Outcome
Title Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
Hide Description Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1.
Time Frame End of Block 1 (Day 36 of Block 1) of re-induction therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3.
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description:
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Overall Number of Participants Analyzed 0 48 40 0 0
Measure Type: Number
Unit of Measure: percentage of participants
35.4 25
6.Secondary Outcome
Title Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2
Hide Description Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2.
Time Frame End of Block 2 (Day 36 of Block 2) of re-induction therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3.
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description:
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Overall Number of Participants Analyzed 0 30 19 0 0
Measure Type: Number
Unit of Measure: percentage of participants
66.7 42.1
7.Secondary Outcome
Title Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
Hide Description Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3.
Time Frame End of Block 3 (Day 36 of Block 3) of re-induction therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The MRD analysis is limited to eligible and evaluable pre-B ALL with age <= 21 years who relapsed < 36 months only (stratum 1 & 2) and have successful MRD determination at the end of Block 3per protocol section 9.3.3.
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description:
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
Overall Number of Participants Analyzed 0 20 11 0 0
Measure Type: Number
Unit of Measure: Percentage of participants
80 63.6
8.Other Pre-specified Outcome
Title NF-kB Activity
Hide Description NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These were for correlative biology studies and the data were not collected in COG database.
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description:

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots
Hide Description Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These were for correlative biology studies and the data were not collected in COG database.
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description:

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Other Pre-specified Outcome
Title Change in Stem Cell Percentage
Hide Description Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test.
Time Frame Baseline to post-treatment with bortezomib
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These were for correlative biology studies and the data were not collected in COG database.
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description:

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Other Pre-specified Outcome
Title Plasma Concentration-time Profiles
Hide Description Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).
Time Frame Up to day 8 of block 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These were for correlative biology studies and the data were not collected in COG database.
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description:

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.

L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9

doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1

therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22

vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22

cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9

prednisone: Given PO or IV 40 mg/m2/day on Days 1-28

bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8

pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22

MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22

etopo

Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Other Pre-specified Outcome
Title Pharmacokinetics (PK) of Bortezomib in Patients Receiving Multi-agent Combination Therapy.
Hide Description This outcome measure cannot be reported due to the data used for analysis was not collected.
Time Frame Day 8 of blocks 1 and 2
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 & higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible & evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.
 
Arm/Group Title Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Hide Arm/Group Description Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2. Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
All-Cause Mortality
Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      47/61 (77.05%)      40/49 (81.63%)      18/22 (81.82%)      7/10 (70.00%)    
Blood and lymphatic system disorders           
Anemia  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Disseminated intravascular coagulation  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Febrile neutropenia  0/4 (0.00%)  0 3/61 (4.92%)  3 3/49 (6.12%)  3 2/22 (9.09%)  2 0/10 (0.00%)  0
Cardiac disorders           
Cardiac arrest  0/4 (0.00%)  0 2/61 (3.28%)  2 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Cardiac disorders - Other, specify  0/4 (0.00%)  0 0/61 (0.00%)  0 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Heart failure  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Left ventricular systolic dysfunction  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Pericardial tamponade  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 1/10 (10.00%)  1
Sinus bradycardia  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Sinus tachycardia  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Ventricular tachycardia  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Eye disorders           
Eye pain  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  0/4 (0.00%)  0 2/61 (3.28%)  2 1/49 (2.04%)  1 1/22 (4.55%)  1 1/10 (10.00%)  1
Anal pain  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Colitis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Dental caries  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Diarrhea  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Enterocolitis  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Esophagitis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Gastric hemorrhage  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Ileus  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 1/22 (4.55%)  1 0/10 (0.00%)  0
Lower gastrointestinal hemorrhage  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Mucositis oral  0/4 (0.00%)  0 3/61 (4.92%)  3 1/49 (2.04%)  1 1/22 (4.55%)  1 0/10 (0.00%)  0
Nausea  0/4 (0.00%)  0 2/61 (3.28%)  2 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Oral pain  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Pancreatic necrosis  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 1/10 (10.00%)  1
Pancreatitis  0/4 (0.00%)  0 1/61 (1.64%)  1 3/49 (6.12%)  3 3/22 (13.64%)  3 1/10 (10.00%)  1
Peritoneal necrosis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Rectal fistula  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Typhlitis  0/4 (0.00%)  0 4/61 (6.56%)  4 1/49 (2.04%)  1 2/22 (9.09%)  2 1/10 (10.00%)  1
Vomiting  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
General disorders           
Chills  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 1/22 (4.55%)  1 0/10 (0.00%)  0
Death NOS  2/4 (50.00%)  2 24/61 (39.34%)  24 24/49 (48.98%)  24 9/22 (40.91%)  9 5/10 (50.00%)  5
Fever  0/4 (0.00%)  0 1/61 (1.64%)  1 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Flu like symptoms  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypothermia  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Multi-organ failure  0/4 (0.00%)  0 3/61 (4.92%)  3 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Pain  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Hepatobiliary disorders           
Hepatobiliary disorders - Other, specify  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Immune system disorders           
Allergic reaction  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Cytokine release syndrome  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Infections and infestations           
Appendicitis  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Appendicitis perforated  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Catheter related infection  0/4 (0.00%)  0 3/61 (4.92%)  3 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Encephalitis infection  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Enterocolitis infectious  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Infections and infestations - Other, specify  0/4 (0.00%)  0 5/61 (8.20%)  5 3/49 (6.12%)  3 2/22 (9.09%)  2 1/10 (10.00%)  1
Infective myositis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Joint infection  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Lung infection  0/4 (0.00%)  0 2/61 (3.28%)  2 2/49 (4.08%)  2 0/22 (0.00%)  0 1/10 (10.00%)  1
Mucosal infection  0/4 (0.00%)  0 2/61 (3.28%)  2 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Papulopustular rash  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Pharyngitis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Sepsis  0/4 (0.00%)  0 8/61 (13.11%)  10 8/49 (16.33%)  8 2/22 (9.09%)  2 1/10 (10.00%)  1
Sinusitis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Soft tissue infection  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Urinary tract infection  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 1/10 (10.00%)  1
Investigations           
Alanine aminotransferase increased  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Aspartate aminotransferase increased  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Blood bilirubin increased  1/4 (25.00%)  1 0/61 (0.00%)  0 0/49 (0.00%)  0 2/22 (9.09%)  2 1/10 (10.00%)  1
Cholesterol high  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Creatinine increased  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Investigations - Other, specify  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 1/10 (10.00%)  1
Lipase increased  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 3/22 (13.64%)  3 1/10 (10.00%)  1
Neutrophil count decreased  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Platelet count decreased  0/4 (0.00%)  0 1/61 (1.64%)  1 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Serum amylase increased  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 1/10 (10.00%)  1
White blood cell decreased  0/4 (0.00%)  0 1/61 (1.64%)  1 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Metabolism and nutrition disorders           
Acidosis  0/4 (0.00%)  0 2/61 (3.28%)  2 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Anorexia  0/4 (0.00%)  0 3/61 (4.92%)  3 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Dehydration  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Hyperglycemia  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  2 1/22 (4.55%)  1 0/10 (0.00%)  0
Hyperkalemia  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypernatremia  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypertriglyceridemia  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 1/22 (4.55%)  1 1/10 (10.00%)  1
Hypoalbuminemia  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 2/22 (9.09%)  2 0/10 (0.00%)  0
Hypocalcemia  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 2/22 (9.09%)  2 0/10 (0.00%)  0
Hypokalemia  0/4 (0.00%)  0 8/61 (13.11%)  8 1/49 (2.04%)  1 1/22 (4.55%)  1 0/10 (0.00%)  0
Hyponatremia  0/4 (0.00%)  0 4/61 (6.56%)  4 4/49 (8.16%)  4 1/22 (4.55%)  1 1/10 (10.00%)  1
Hypophosphatemia  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 1/10 (10.00%)  1
Tumor lysis syndrome  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Back pain  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Joint effusion  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Pain in extremity  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  0/4 (0.00%)  0 3/61 (4.92%)  3 4/49 (8.16%)  4 2/22 (9.09%)  2 0/10 (0.00%)  0
Nervous system disorders           
Akathisia  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Depressed level of consciousness  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Dysarthria  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Encephalopathy  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Headache  0/4 (0.00%)  0 2/61 (3.28%)  2 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Memory impairment  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Nervous system disorders - Other, specify  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Neuralgia  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Paresthesia  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Peripheral sensory neuropathy  1/4 (25.00%)  1 0/61 (0.00%)  0 1/49 (2.04%)  1 1/22 (4.55%)  1 0/10 (0.00%)  0
Reversible posterior leukoencephalopathy syndrome  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Seizure  0/4 (0.00%)  0 2/61 (3.28%)  2 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Stroke  0/4 (0.00%)  0 0/61 (0.00%)  0 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Syncope  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Psychiatric disorders           
Anxiety  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Confusion  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Psychiatric disorders - Other, specify  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Urinary retention  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Adult respiratory distress syndrome  0/4 (0.00%)  0 2/61 (3.28%)  2 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Atelectasis  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Bronchopulmonary hemorrhage  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Dyspnea  0/4 (0.00%)  0 2/61 (3.28%)  2 3/49 (6.12%)  3 0/22 (0.00%)  0 0/10 (0.00%)  0
Epistaxis  0/4 (0.00%)  0 0/61 (0.00%)  0 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypoxia  0/4 (0.00%)  0 8/61 (13.11%)  8 3/49 (6.12%)  3 0/22 (0.00%)  0 0/10 (0.00%)  0
Pharyngolaryngeal pain  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Pleural effusion  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Pneumonitis  0/4 (0.00%)  0 2/61 (3.28%)  2 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Pneumothorax  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Pulmonary edema  0/4 (0.00%)  0 3/61 (4.92%)  3 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Respiratory failure  0/4 (0.00%)  0 5/61 (8.20%)  5 4/49 (8.16%)  4 1/22 (4.55%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Stridor  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Wheezing  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders           
Pruritus  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Rash maculo-papular  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Skin ulceration  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Toxic epidermal necrolysis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Vascular disorders           
Capillary leak syndrome  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 1/10 (10.00%)  1
Hypertension  0/4 (0.00%)  0 3/61 (4.92%)  3 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypotension  0/4 (0.00%)  0 8/61 (13.11%)  8 5/49 (10.20%)  5 3/22 (13.64%)  3 1/10 (10.00%)  1
1
Term from vocabulary, CTCV4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs T-cell ALL (Chemotherapy) T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      58/61 (95.08%)      44/49 (89.80%)      21/22 (95.45%)      9/10 (90.00%)    
Blood and lymphatic system disorders           
Anemia  3/4 (75.00%)  3 41/61 (67.21%)  47 27/49 (55.10%)  29 17/22 (77.27%)  17 7/10 (70.00%)  7
Blood and lymphatic system disorders - Other, specify  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Febrile neutropenia  0/4 (0.00%)  0 23/61 (37.70%)  23 22/49 (44.90%)  22 10/22 (45.45%)  10 2/10 (20.00%)  2
Cardiac disorders           
Pericardial effusion  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 1/10 (10.00%)  1
Ventricular tachycardia  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Eye disorders           
Conjunctivitis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal disorders           
Abdominal distension  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Abdominal pain  0/4 (0.00%)  0 3/61 (4.92%)  3 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Anal fistula  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Anal pain  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Ascites  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Colitis  1/4 (25.00%)  1 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Diarrhea  0/4 (0.00%)  0 4/61 (6.56%)  4 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Enterocolitis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Gastric hemorrhage  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Gastrointestinal pain  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Hemorrhoidal hemorrhage  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Ileus  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 1/10 (10.00%)  1
Mucositis oral  0/4 (0.00%)  0 7/61 (11.48%)  7 4/49 (8.16%)  4 1/22 (4.55%)  1 0/10 (0.00%)  0
Nausea  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Oral pain  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Pancreatitis  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Proctitis  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Rectal pain  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 2/22 (9.09%)  2 0/10 (0.00%)  0
Rectal ulcer  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Typhlitis  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Vomiting  1/4 (25.00%)  1 2/61 (3.28%)  2 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
General disorders           
Facial pain  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Fatigue  0/4 (0.00%)  0 2/61 (3.28%)  2 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Fever  0/4 (0.00%)  0 8/61 (13.11%)  8 3/49 (6.12%)  3 1/22 (4.55%)  1 1/10 (10.00%)  1
Infusion related reaction  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Pain  1/4 (25.00%)  1 0/61 (0.00%)  0 1/49 (2.04%)  1 1/22 (4.55%)  1 1/10 (10.00%)  1
Infections and infestations           
Anorectal infection  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Appendicitis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Bladder infection  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 1/10 (10.00%)  1
Bronchial infection  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Catheter related infection  1/4 (25.00%)  1 11/61 (18.03%)  12 8/49 (16.33%)  8 4/22 (18.18%)  4 0/10 (0.00%)  0
Conjunctivitis infective  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Enterocolitis infectious  0/4 (0.00%)  0 3/61 (4.92%)  3 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Eye infection  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Hepatic infection  1/4 (25.00%)  1 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Infections and infestations - Other, specify  1/4 (25.00%)  1 20/61 (32.79%)  22 15/49 (30.61%)  16 7/22 (31.82%)  8 4/10 (40.00%)  5
Kidney infection  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Lung infection  0/4 (0.00%)  0 6/61 (9.84%)  6 1/49 (2.04%)  1 1/22 (4.55%)  1 2/10 (20.00%)  2
Nail infection  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Paronychia  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Periorbital infection  0/4 (0.00%)  0 0/61 (0.00%)  0 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Peritoneal infection  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Sepsis  0/4 (0.00%)  0 6/61 (9.84%)  6 5/49 (10.20%)  5 2/22 (9.09%)  2 0/10 (0.00%)  0
Sinusitis  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Skin infection  0/4 (0.00%)  0 3/61 (4.92%)  3 1/49 (2.04%)  1 0/22 (0.00%)  0 2/10 (20.00%)  2
Soft tissue infection  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Splenic infection  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Urinary tract infection  1/4 (25.00%)  1 5/61 (8.20%)  5 2/49 (4.08%)  2 1/22 (4.55%)  1 1/10 (10.00%)  1
Wound infection  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Injury, poisoning and procedural complications           
Postoperative hemorrhage  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Investigations           
Activated partial thromboplastin time prolonged  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 1/10 (10.00%)  1
Alanine aminotransferase increased  2/4 (50.00%)  2 15/61 (24.59%)  15 8/49 (16.33%)  8 3/22 (13.64%)  3 3/10 (30.00%)  4
Alkaline phosphatase increased  2/4 (50.00%)  2 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Aspartate aminotransferase increased  1/4 (25.00%)  1 8/61 (13.11%)  8 4/49 (8.16%)  4 3/22 (13.64%)  3 2/10 (20.00%)  2
Blood bilirubin increased  0/4 (0.00%)  0 2/61 (3.28%)  2 2/49 (4.08%)  2 0/22 (0.00%)  0 1/10 (10.00%)  1
Creatinine increased  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Ejection fraction decreased  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Electrocardiogram QT corrected interval prolonged  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Fibrinogen decreased  1/4 (25.00%)  1 2/61 (3.28%)  2 1/49 (2.04%)  1 1/22 (4.55%)  1 2/10 (20.00%)  2
Forced expiratory volume decreased  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
GGT increased  0/4 (0.00%)  0 2/61 (3.28%)  2 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Investigations - Other, specify  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Lipase increased  0/4 (0.00%)  0 7/61 (11.48%)  7 3/49 (6.12%)  3 1/22 (4.55%)  1 0/10 (0.00%)  0
Lymphocyte count decreased  2/4 (50.00%)  3 16/61 (26.23%)  19 16/49 (32.65%)  21 5/22 (22.73%)  6 2/10 (20.00%)  2
Lymphocyte count increased  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Neutrophil count decreased  3/4 (75.00%)  3 39/61 (63.93%)  45 30/49 (61.22%)  34 18/22 (81.82%)  20 9/10 (90.00%)  10
Platelet count decreased  3/4 (75.00%)  4 44/61 (72.13%)  50 32/49 (65.31%)  39 18/22 (81.82%)  20 9/10 (90.00%)  10
Serum amylase increased  0/4 (0.00%)  0 3/61 (4.92%)  3 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Weight loss  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
White blood cell decreased  3/4 (75.00%)  3 38/61 (62.30%)  44 29/49 (59.18%)  31 12/22 (54.55%)  15 7/10 (70.00%)  9
Metabolism and nutrition disorders           
Acidosis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Anorexia  0/4 (0.00%)  0 6/61 (9.84%)  6 3/49 (6.12%)  3 1/22 (4.55%)  1 1/10 (10.00%)  1
Dehydration  0/4 (0.00%)  0 3/61 (4.92%)  3 0/49 (0.00%)  0 1/22 (4.55%)  1 1/10 (10.00%)  1
Glucose intolerance  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypercalcemia  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Hyperglycemia  1/4 (25.00%)  1 10/61 (16.39%)  11 5/49 (10.20%)  5 3/22 (13.64%)  3 0/10 (0.00%)  0
Hyperkalemia  1/4 (25.00%)  1 0/61 (0.00%)  0 2/49 (4.08%)  2 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypermagnesemia  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypertriglyceridemia  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Hyperuricemia  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypoalbuminemia  1/4 (25.00%)  1 3/61 (4.92%)  3 6/49 (12.24%)  6 3/22 (13.64%)  3 2/10 (20.00%)  2
Hypocalcemia  1/4 (25.00%)  1 7/61 (11.48%)  9 5/49 (10.20%)  5 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypoglycemia  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 1/22 (4.55%)  1 1/10 (10.00%)  1
Hypokalemia  2/4 (50.00%)  2 15/61 (24.59%)  16 13/49 (26.53%)  14 6/22 (27.27%)  6 3/10 (30.00%)  3
Hypomagnesemia  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Hyponatremia  0/4 (0.00%)  0 6/61 (9.84%)  6 4/49 (8.16%)  4 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypophosphatemia  0/4 (0.00%)  0 7/61 (11.48%)  7 5/49 (10.20%)  5 0/22 (0.00%)  0 1/10 (10.00%)  1
Tumor lysis syndrome  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 3/22 (13.64%)  3 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 3/10 (30.00%)  3
Generalized muscle weakness  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Muscle weakness lower limb  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Myalgia  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 1/22 (4.55%)  1 0/10 (0.00%)  0
Pain in extremity  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 1/22 (4.55%)  1 0/10 (0.00%)  0
Nervous system disorders           
Dizziness  0/4 (0.00%)  0 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 1/10 (10.00%)  1
Headache  1/4 (25.00%)  1 2/61 (3.28%)  2 0/49 (0.00%)  0 2/22 (9.09%)  2 0/10 (0.00%)  0
Nervous system disorders - Other, specify  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Peripheral motor neuropathy  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 1/22 (4.55%)  1 0/10 (0.00%)  0
Peripheral sensory neuropathy  0/4 (0.00%)  0 2/61 (3.28%)  2 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Syncope  1/4 (25.00%)  1 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Tremor  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Psychiatric disorders           
Agitation  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 1/22 (4.55%)  1 0/10 (0.00%)  0
Anxiety  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Confusion  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Delirium  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Depression  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Psychosis  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Dyspnea  0/4 (0.00%)  0 3/61 (4.92%)  3 1/49 (2.04%)  1 0/22 (0.00%)  0 1/10 (10.00%)  1
Epistaxis  1/4 (25.00%)  1 0/61 (0.00%)  0 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypoxia  0/4 (0.00%)  0 2/61 (3.28%)  2 1/49 (2.04%)  1 1/22 (4.55%)  1 1/10 (10.00%)  1
Pharyngeal mucositis  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Pneumonitis  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Pulmonary edema  0/4 (0.00%)  0 1/61 (1.64%)  1 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Respiratory failure  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders           
Rash maculo-papular  0/4 (0.00%)  0 2/61 (3.28%)  2 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Stevens-Johnson syndrome  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Vascular disorders           
Capillary leak syndrome  0/4 (0.00%)  0 1/61 (1.64%)  1 0/49 (0.00%)  0 0/22 (0.00%)  0 0/10 (0.00%)  0
Hematoma  0/4 (0.00%)  0 0/61 (0.00%)  0 1/49 (2.04%)  1 0/22 (0.00%)  0 0/10 (0.00%)  0
Hypertension  0/4 (0.00%)  0 5/61 (8.20%)  5 0/49 (0.00%)  0 0/22 (0.00%)  0 2/10 (20.00%)  2
Hypotension  0/4 (0.00%)  0 4/61 (6.56%)  4 6/49 (12.24%)  6 1/22 (4.55%)  1 0/10 (0.00%)  0
1
Term from vocabulary, CTCV4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00873093     History of Changes
Other Study ID Numbers: NCI-2011-01908
NCI-2011-01908 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AALL07P1 ( Other Identifier: Children's Oncology Group )
AALL07P1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: March 31, 2009
First Posted: April 1, 2009
Results First Submitted: February 9, 2016
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017