Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 88 for:    "Acute Lymphoblastic Leukemia, Childhood" | "Antineoplastic Agents, Hormonal"

Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00671034
Recruitment Status : Completed
First Posted : May 2, 2008
Results First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions B-cell Adult Acute Lymphoblastic Leukemia
B-cell Childhood Acute Lymphoblastic Leukemia
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Interventions Drug: calaspargase pegol
Drug: Pegaspargase
Drug: DOXOrubicin Hydrochloride
Drug: Cytarabine
Drug: Prednisone
Drug: methotrexate
Drug: cyclophosphamide
Drug: mercaptopurine tablet
Drug: Dexamethasone
Drug: thioguanine
Drug: DAUNOrubicin Hydrochloride
Drug: vincristine sulfate
Radiation: radiation therapy
Other: laboratory biomarker analysis
Other: pharmacological study
Enrollment 166
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years. Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Period Title: Overall Study
Started 69 42 55
Completed 30 22 31
Not Completed 39 20 24
Reason Not Completed
Adverse Event             5             7             1
Death             3             2             1
Physician Decision             12             4             5
VHR ALL feature             8             3             5
Refusal             5             3             5
includes Alternative therapy, etc.             6             1             7
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500) Total
Hide Arm/Group Description calaspargase pegol 2100 calaspargase pegol 2500 pegaspargase 2500 Total of all reporting groups
Overall Number of Baseline Participants 69 42 55 166
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 42 participants 55 participants 166 participants
<=18 years
62
  89.9%
40
  95.2%
51
  92.7%
153
  92.2%
Between 18 and 65 years
7
  10.1%
2
   4.8%
4
   7.3%
13
   7.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 42 participants 55 participants 166 participants
11.9  (5.58) 9.9  (6.09) 10.79  (5.54) 11.3  (5.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 42 participants 55 participants 166 participants
Female
31
  44.9%
28
  66.7%
23
  41.8%
82
  49.4%
Male
38
  55.1%
14
  33.3%
32
  58.2%
84
  50.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 42 participants 55 participants 166 participants
Hispanic or Latino
14
  20.3%
12
  28.6%
18
  32.7%
44
  26.5%
Not Hispanic or Latino
53
  76.8%
28
  66.7%
35
  63.6%
116
  69.9%
Unknown or Not Reported
2
   2.9%
2
   4.8%
2
   3.6%
6
   3.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 42 participants 55 participants 166 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   5.8%
1
   2.4%
1
   1.8%
6
   3.6%
Native Hawaiian or Other Pacific Islander
1
   1.4%
1
   2.4%
0
   0.0%
2
   1.2%
Black or African American
4
   5.8%
1
   2.4%
6
  10.9%
11
   6.6%
White
56
  81.2%
35
  83.3%
43
  78.2%
134
  80.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   5.8%
4
   9.5%
5
   9.1%
13
   7.8%
1.Primary Outcome
Title Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)
Hide Description Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half.
Time Frame Post Day 29 of Induction and Post Day 22 of Consolidation
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis restricted to patients who had PK data collected
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II ( Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description:
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Overall Number of Participants Analyzed 69 42 54
Mean (Standard Deviation)
Unit of Measure: hours
Asparaginase half-life during Consolidation Number Analyzed 24 participants 17 participants 24 participants
415.8  (148.51) 355.9  (133.0) 117.2  (49.36)
Asparaginase half-life during Induction Number Analyzed 58 participants 40 participants 43 participants
305.1  (98.33) 321.5  (118.22) 126.9  (50.51)
2.Secondary Outcome
Title Pharmacodynamics (PD)
Hide Description Plasma Asparaginase Concentration During consolidation and induction.
Time Frame Day 29 of consolidation and induction
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had data collected
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description:
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Overall Number of Participants Analyzed 69 42 54
Median (Standard Deviation)
Unit of Measure: mIU/mL
Plasma Asparaginase Concentration- Consolidation Number Analyzed 33 participants 18 participants 30 participants
575.9  (233.91) 617.2  (321.41) 562.1  (296.82)
Plasma Asparaginase Concentration- Induction Number Analyzed 59 participants 40 participants 42 participants
271.6  (118.17) 339.6  (126.83) 72.8  (47.94)
3.Secondary Outcome
Title Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction
Hide Description Percentage of participants with Negative MRD (MRD<0.01%).
Time Frame End of induction (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had data collected.
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description:
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Overall Number of Participants Analyzed 62 40 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
65.2
(52.4 to 76.5)
81
(65.9 to 91.4)
72.5
(58.3 to 84.1)
4.Secondary Outcome
Title Percentage of Participants With Complete Remission at the End of Induction
Hide Description Complete Remission (CR) rate; where CR is defined as M1 marrow (< 5% lymphoblasts in the bone marrow)
Time Frame End of induction (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had data collected
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description:
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Overall Number of Participants Analyzed 66 42 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
92.4
(83.2 to 97.5)
97.6
(87.4 to 99.9)
94.1
(83.8 to 98.8)
5.Secondary Outcome
Title Percentage of Participants With Event-free Survival (EFS)
Hide Description Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free.
Time Frame 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description:
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Overall Number of Participants Analyzed 69 42 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
72.35
(60.98 to 83.72)
80.8
(68.3 to 93.3)
79.34
(67.56 to 91.12)
6.Secondary Outcome
Title Asparaginase Level
Hide Description The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar
Time Frame Days 4, 15, 22 and 29 of Induction
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had data collected.
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description:
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Overall Number of Participants Analyzed 69 42 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
Level at least 0.1 IU/mL day 4 Number Analyzed 62 participants 40 participants 43 participants
0
(0.0 to 8.2)
0
(0.0 to 8.8)
0
(0.0 to 5.8)
Level at least 0.1 IU/mL day 15 Number Analyzed 62 participants 40 participants 43 participants
98.4
(91.3 to 100.0)
100
(91.2 to 100)
100
(98.1 to 100)
Level at least 0.1 IU/mL day 22 Number Analyzed 56 participants 40 participants 41 participants
98.2
(78.1 to 98.5)
100
(91.2 to 100)
95.1
(77.9 to 97.4)
Level at least 0.1 IU/mL day 29 Number Analyzed 59 participants 40 participants 42 participants
94.9
(80.1 to 96.4)
95.0
(83.1 to 99.4)
28.6
(15.3 to 43.7)
Level at least 0.4 IU/mL day 4 Number Analyzed 62 participants 40 participants 43 participants
0
(0.0 to 8.2)
0
(0.0 to 8.8)
0
(0.0 to 5.8)
Level at least 0.4 IU/mL day 15 Number Analyzed 62 participants 40 participants 43 participants
75.8
(63.3 to 85.8)
95.0
(83.1 to 99.4)
93.0
(80.9 to 98.5)
Level at least 0.4 IU/mL day 22 Number Analyzed 56 participants 40 participants 41 participants
37.5
(22.3 to 47.0)
62.5
(45.8 to 77.3)
14.6
(5.3 to 27.9)
Level at least 0.4 IU/mL day 29 Number Analyzed 59 participants 40 participants 42 participants
13.6
(5.7 to 23.9)
27.5
(14.6 to 43.9)
0
(0.0 to 8.2)
7.Secondary Outcome
Title Plasma and CSF Concentrations of Asparagine in ug/ml
Hide Description The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar.
Time Frame 25 Days Post-dose (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had data collected.
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description:
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Overall Number of Participants Analyzed 69 42 54
Mean (Standard Deviation)
Unit of Measure: ug/mL
CSF asparagine concentration (ug/mL) Number Analyzed 51 participants 38 participants 38 participants
0.2  (0.108) 0.19  (0.086) 0.26  (0.26)
Plasma asparagine concentration (ug/mL) Number Analyzed 55 participants 39 participants 41 participants
0.2  (0.784) 0.25  (1.231) 0.83  (2.195)
8.Secondary Outcome
Title Immunogenicity
Hide Description Number of Patients with Positive Immunogenicity tests
Time Frame 25 Days Post-dose (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had data collected.
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description:
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Overall Number of Participants Analyzed 69 42 54
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.9%
2
   4.8%
4
   7.4%
9.Secondary Outcome
Title Toxicities During Post Induction Intensification Therapy (All Grades)
Hide Description The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had data collected. International normalized ratio (INR). Activated partial thromboplastin (APT)
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description:
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Overall Number of Participants Analyzed 49 33 43
Measure Type: Number
Unit of Measure: Percentage of participants
Alergic Reaction - Consolidation Number Analyzed 49 participants 33 participants 43 participants
20.4 27.3 23.3
Alergic Reaction - Delayed Intensification I Number Analyzed 45 participants 26 participants 38 participants
4.4 0.0 0.0
Alergic Reaction - Interim Maintenance I Number Analyzed 46 participants 29 participants 39 participants
0.0 0.0 2.1
CNS - Consolidation Number Analyzed 49 participants 33 participants 43 participants
0.0 0.0 0.0
CNS - Delayed Intensification I Number Analyzed 45 participants 26 participants 38 participants
0.0 3.8 2.6
CNS - Interim Maintenance I Number Analyzed 46 participants 29 participants 39 participants
0.0 0.0 0.0
Hyperbilirubinemia - Consolidation Number Analyzed 49 participants 33 participants 43 participants
53.1 45.5 30.2
Hyperbilirubinemia - Delayed Intensification I Number Analyzed 45 participants 26 participants 38 participants
28.9 38.5 10.5
Hyperbilirubinemia - Interim Maintenance I Number Analyzed 46 participants 29 participants 39 participants
41.3 27.6 33.3
Hyperglycemia - Consolidation Number Analyzed 49 participants 33 participants 43 participants
44.9 42.4 46.5
Hyperglycemia - Delayed Intensification I Number Analyzed 45 participants 26 participants 38 participants
44.4 61.5 36.8
Hyperglycemia - Interim Maintenance I Number Analyzed 46 participants 29 participants 39 participants
34.8 44.8 33.3
Hyperlipidemia - Consolidation Number Analyzed 49 participants 33 participants 43 participants
2.0 3.0 7.0
Hyperlipidemia - Delayed Intensification I Number Analyzed 45 participants 26 participants 38 participants
2.2 0.0 0.0
Hyperlipidemia - Interim Maintenance I Number Analyzed 46 participants 29 participants 39 participants
2.2 3.4 2.6
% patients w/INR increase - Consolidation Number Analyzed 49 participants 33 participants 43 participants
6.1 3.0 7.0
% pts w/INR increase - Delayed Intensification I Number Analyzed 45 participants 26 participants 38 participants
6.7 3.8 0.0
% patients w/INR increase - Interim Maintenance I Number Analyzed 46 participants 29 participants 39 participants
2.2 0.0 2.6
Pancreatitis - Consolidation Number Analyzed 49 participants 33 participants 43 participants
10.2 6.1 7.0
Pancreatitis -Delayed Intensification I Number Analyzed 45 participants 26 participants 38 participants
2.2 7.7 0.0
Pancreatitis - Interim Maintenance I Number Analyzed 46 participants 29 participants 39 participants
2.2 3.4 2.6
% pts w/prolongation of APT time - Consolidation Number Analyzed 49 participants 33 participants 43 participants
8.2 9.1 7.0
% pts w/prolongation APT time -Delayed Intension I Number Analyzed 45 participants 26 participants 38 participants
8.9 26.9 18.4
%pts w/prolongation APT time-Interim maintenance I Number Analyzed 46 participants 29 participants 39 participants
6.5 6.9 7.7
Thrombosis - Consolidation Number Analyzed 49 participants 33 participants 43 participants
0.0 0.0 2.3
Thrombosis - Delayed Intensification I Number Analyzed 45 participants 26 participants 38 participants
2.2 0.0 0.0
Thrombosis - Interim Maintenance I Number Analyzed 46 participants 29 participants 39 participants
0.0 0.0 0.0
10.Secondary Outcome
Title Relationship Between PK and Presence of Antibodies
Hide Description Patients with presence of Antibodies.
Time Frame Day 29 of consolidation
Hide Outcome Measure Data
Hide Analysis Population Description
These data will never be collected.
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description:
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive calaspargase pegol together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo radiation therapy to the head. Treatment may continue for up to 3 1/2 years.
Patients receive pegaspargase together with combination chemotherapy. Patients receive chemotherapy PO, IV, SC, and IT. Some patients also undergo RT to the head. Treatment may continue for up to 3 1/2 years.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Hide Arm/Group Description calaspargase pegol 2100 calaspargase pegol 2500 pegaspargase 2500
All-Cause Mortality
Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/69 (78.26%)      34/42 (80.95%)      32/54 (59.26%)    
Blood and lymphatic system disorders       
Anemia  1/69 (1.45%)  1 1/42 (2.38%)  1 1/54 (1.85%)  1
Febrile neutropenia  1/69 (1.45%)  1 4/42 (9.52%)  4 2/54 (3.70%)  2
Hemolysis  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Cardiac disorders       
Cardiac disorders - Other, specify  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Supraventricular tachycardia  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  11/69 (15.94%)  14 7/42 (16.67%)  7 4/54 (7.41%)  4
Anal pain  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Ascites  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Constipation  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Duodenal perforation  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Mucositis oral  1/69 (1.45%)  1 1/42 (2.38%)  1 2/54 (3.70%)  2
Nausea  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Oral pain  3/69 (4.35%)  5 0/42 (0.00%)  0 1/54 (1.85%)  1
Pancreatic necrosis  1/69 (1.45%)  1 0/42 (0.00%)  0 1/54 (1.85%)  1
Pancreatitis  8/69 (11.59%)  8 6/42 (14.29%)  6 4/54 (7.41%)  4
Rectal pain  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Typhlitis  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Vomiting  0/69 (0.00%)  0 2/42 (4.76%)  2 2/54 (3.70%)  2
General disorders       
Death NOS  4/69 (5.80%)  4 1/42 (2.38%)  1 1/54 (1.85%)  1
Fatigue  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Fever  2/69 (2.90%)  2 0/42 (0.00%)  0 1/54 (1.85%)  1
Irritability  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Pain  2/69 (2.90%)  2 2/42 (4.76%)  2 1/54 (1.85%)  2
Hepatobiliary disorders       
Hepatobiliary disorders - Other, specify  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Immune system disorders       
Anaphylaxis  13/69 (18.84%)  13 11/42 (26.19%)  11 10/54 (18.52%)  11
Infections and infestations       
Enterocolitis infectious  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Infections and infestations - Other, specify  14/69 (20.29%)  17 8/42 (19.05%)  10 4/54 (7.41%)  6
Infective myositis  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Lung infection  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Sepsis  2/69 (2.90%)  2 1/42 (2.38%)  1 0/54 (0.00%)  0
Urinary tract infection  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Investigations       
Activated partial thromboplastin time prolonged  3/69 (4.35%)  3 3/42 (7.14%)  3 3/54 (5.56%)  3
Alanine aminotransferase increased  4/69 (5.80%)  4 2/42 (4.76%)  3 5/54 (9.26%)  6
Aspartate aminotransferase increased  5/69 (7.25%)  5 2/42 (4.76%)  2 4/54 (7.41%)  4
Blood bilirubin increased  12/69 (17.39%)  13 8/42 (19.05%)  10 10/54 (18.52%)  12
CPK increased  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Cholesterol high  2/69 (2.90%)  4 2/42 (4.76%)  4 3/54 (5.56%)  5
Creatinine increased  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Fibrinogen decreased  4/69 (5.80%)  4 3/42 (7.14%)  3 3/54 (5.56%)  3
GGT increased  1/69 (1.45%)  1 2/42 (4.76%)  2 1/54 (1.85%)  1
INR increased  1/69 (1.45%)  1 3/42 (7.14%)  3 0/54 (0.00%)  0
Investigations - Other, specify  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Lipase increased  7/69 (10.14%)  7 4/42 (9.52%)  4 4/54 (7.41%)  4
Lymphocyte count decreased  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Neutrophil count decreased  2/69 (2.90%)  2 0/42 (0.00%)  0 2/54 (3.70%)  2
Platelet count decreased  6/69 (8.70%)  6 1/42 (2.38%)  1 1/54 (1.85%)  2
Serum amylase increased  8/69 (11.59%)  8 1/42 (2.38%)  1 2/54 (3.70%)  2
Weight loss  3/69 (4.35%)  3 2/42 (4.76%)  2 1/54 (1.85%)  7
White blood cell decreased  1/69 (1.45%)  1 2/42 (4.76%)  2 1/54 (1.85%)  1
Metabolism and nutrition disorders       
Acidosis  0/69 (0.00%)  0 2/42 (4.76%)  2 0/54 (0.00%)  0
Anorexia  5/69 (7.25%)  7 1/42 (2.38%)  10 1/54 (1.85%)  7
Dehydration  2/69 (2.90%)  3 1/42 (2.38%)  1 3/54 (5.56%)  4
Glucose intolerance  2/69 (2.90%)  2 0/42 (0.00%)  0 1/54 (1.85%)  1
Hyperglycemia  21/69 (30.43%)  27 14/42 (33.33%)  16 12/54 (22.22%)  17
Hyperkalemia  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Hypertriglyceridemia  5/69 (7.25%)  7 4/42 (9.52%)  7 6/54 (11.11%)  10
Hyperuricemia  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Hypoalbuminemia  5/69 (7.25%)  6 2/42 (4.76%)  2 1/54 (1.85%)  1
Hypocalcemia  3/69 (4.35%)  3 0/42 (0.00%)  0 2/54 (3.70%)  2
Hypokalemia  4/69 (5.80%)  4 0/42 (0.00%)  0 0/54 (0.00%)  0
Hyponatremia  3/69 (4.35%)  3 0/42 (0.00%)  0 0/54 (0.00%)  0
Hypophosphatemia  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Tumor lysis syndrome  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Back pain  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Chest wall pain  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Generalized muscle weakness  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Joint effusion  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Muscle weakness left-sided  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Muscle weakness right-sided  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Myalgia  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Myositis  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Pain in extremity  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Nervous system disorders       
Arachnoiditis  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Ataxia  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Depressed level of consciousness  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Dizziness  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Dysphasia  2/69 (2.90%)  2 1/42 (2.38%)  2 0/54 (0.00%)  0
Encephalopathy  2/69 (2.90%)  2 3/42 (7.14%)  3 1/54 (1.85%)  1
Headache  2/69 (2.90%)  3 0/42 (0.00%)  0 1/54 (1.85%)  1
Intracranial hemorrhage  1/69 (1.45%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Leukoencephalopathy  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Nervous system disorders - Other, specify  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Seizure  2/69 (2.90%)  2 2/42 (4.76%)  2 1/54 (1.85%)  1
Syncope  2/69 (2.90%)  2 2/42 (4.76%)  2 3/54 (5.56%)  3
Psychiatric disorders       
Agitation  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Anxiety  1/69 (1.45%)  1 2/42 (4.76%)  2 0/54 (0.00%)  0
Confusion  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Depression  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Psychosis  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  2/69 (2.90%)  2 0/42 (0.00%)  0 2/54 (3.70%)  2
Chronic kidney disease  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Cough  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Dyspnea  3/69 (4.35%)  3 1/42 (2.38%)  1 1/54 (1.85%)  1
Epistaxis  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Hypoxia  6/69 (8.70%)  6 3/42 (7.14%)  3 3/54 (5.56%)  3
Pleural effusion  3/69 (4.35%)  3 0/42 (0.00%)  0 0/54 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Skin and subcutaneous tissue disorders       
Erythema multiforme  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Purpura  1/69 (1.45%)  1 1/42 (2.38%)  1 0/54 (0.00%)  0
Rash maculo-papular  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Vascular disorders       
Hematoma  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Hypertension  3/69 (4.35%)  3 0/42 (0.00%)  0 3/54 (5.56%)  3
Hypotension  7/69 (10.14%)  7 1/42 (2.38%)  1 1/54 (1.85%)  1
Thromboembolic event  5/69 (7.25%)  7 0/42 (0.00%)  0 1/54 (1.85%)  1
Vascular disorders - Other, specify  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
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%
Arm I (Calaspargase Pegol 2100) Arm II (Calaspargase Pegol 2500) Arm III (Pegaspargase 2500)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   64/69 (92.75%)      40/42 (95.24%)      51/54 (94.44%)    
Blood and lymphatic system disorders       
Anemia  18/69 (26.09%)  23 16/42 (38.10%)  27 23/54 (42.59%)  33
Blood and lymphatic system disorders - Other, specify  1/69 (1.45%)  1 0/42 (0.00%)  0 1/54 (1.85%)  1
Disseminated intravascular coagulation  1/69 (1.45%)  1 1/42 (2.38%)  1 0/54 (0.00%)  0
Febrile neutropenia  37/69 (53.62%)  88 26/42 (61.90%)  60 31/54 (57.41%)  56
Hemolysis  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Cardiac disorders       
Left ventricular systolic dysfunction  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Sinus tachycardia  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Ear and labyrinth disorders       
Middle ear inflammation  1/69 (1.45%)  1 1/42 (2.38%)  1 0/54 (0.00%)  0
Eye disorders       
Eye disorders - Other, specify  1/69 (1.45%)  2 0/42 (0.00%)  0 1/54 (1.85%)  1
Retinal detachment  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Vitreous hemorrhage  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Gastrointestinal disorders       
Abdominal pain  7/69 (10.14%)  7 8/42 (19.05%)  8 6/54 (11.11%)  9
Anal pain  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Ascites  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Colitis  1/69 (1.45%)  1 0/42 (0.00%)  0 1/54 (1.85%)  1
Diarrhea  8/69 (11.59%)  10 4/42 (9.52%)  6 2/54 (3.70%)  2
Enterocolitis  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Esophagitis  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Fecal incontinence  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Gastritis  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Ileus  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Lower gastrointestinal hemorrhage  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Malabsorption  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Mucositis oral  16/69 (23.19%)  23 4/42 (9.52%)  5 7/54 (12.96%)  9
Nausea  9/69 (13.04%)  10 3/42 (7.14%)  3 2/54 (3.70%)  3
Oral hemorrhage  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Oral pain  6/69 (8.70%)  7 1/42 (2.38%)  1 1/54 (1.85%)  1
Pancreatitis  1/69 (1.45%)  1 2/42 (4.76%)  3 0/54 (0.00%)  0
Vomiting  5/69 (7.25%)  7 2/42 (4.76%)  3 5/54 (9.26%)  5
General disorders       
Facial pain  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Fatigue  3/69 (4.35%)  4 3/42 (7.14%)  4 2/54 (3.70%)  2
Fever  3/69 (4.35%)  4 5/42 (11.90%)  5 3/54 (5.56%)  3
Irritability  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Multi-organ failure  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Non-cardiac chest pain  2/69 (2.90%)  2 3/42 (7.14%)  3 2/54 (3.70%)  2
Pain  5/69 (7.25%)  10 1/42 (2.38%)  1 2/54 (3.70%)  3
Hepatobiliary disorders       
Cholecystitis  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Immune system disorders       
Anaphylaxis  2/69 (2.90%)  2 2/42 (4.76%)  2 1/54 (1.85%)  1
Infections and infestations       
Abdominal infection  0/69 (0.00%)  0 1/42 (2.38%)  1 1/54 (1.85%)  1
Anorectal infection  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Bladder infection  0/69 (0.00%)  0 1/42 (2.38%)  1 1/54 (1.85%)  1
Catheter related infection  2/69 (2.90%)  2 0/42 (0.00%)  0 1/54 (1.85%)  1
Enterocolitis infectious  5/69 (7.25%)  6 1/42 (2.38%)  1 1/54 (1.85%)  2
Infections and infestations - Other, specify  30/69 (43.48%)  57 23/42 (54.76%)  55 18/54 (33.33%)  39
Infective myositis  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Lip infection  1/69 (1.45%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Lung infection  8/69 (11.59%)  9 3/42 (7.14%)  3 0/54 (0.00%)  0
Mucosal infection  1/69 (1.45%)  1 0/42 (0.00%)  0 1/54 (1.85%)  1
Otitis media  0/69 (0.00%)  0 0/42 (0.00%)  0 2/54 (3.70%)  2
Pancreas infection  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Paronychia  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Peripheral nerve infection  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Pharyngitis  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Scrotal infection  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Sepsis  3/69 (4.35%)  3 0/42 (0.00%)  0 1/54 (1.85%)  1
Sinusitis  1/69 (1.45%)  1 0/42 (0.00%)  0 2/54 (3.70%)  2
Skin infection  3/69 (4.35%)  4 2/42 (4.76%)  2 2/54 (3.70%)  3
Stoma site infection  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Upper respiratory infection  3/69 (4.35%)  3 1/42 (2.38%)  1 1/54 (1.85%)  1
Urinary tract infection  4/69 (5.80%)  5 2/42 (4.76%)  2 1/54 (1.85%)  1
Wound infection  1/69 (1.45%)  1 1/42 (2.38%)  1 0/54 (0.00%)  0
Injury, poisoning and procedural complications       
Injury, poisoning and procedural complications - Other, specify  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Tracheal obstruction  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Vascular access complication  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Wound dehiscence  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Investigations       
Activated partial thromboplastin time prolonged  1/69 (1.45%)  1 0/42 (0.00%)  0 1/54 (1.85%)  1
Alanine aminotransferase increased  25/69 (36.23%)  71 22/42 (52.38%)  47 27/54 (50.00%)  73
Alkaline phosphatase increased  3/69 (4.35%)  3 1/42 (2.38%)  1 0/54 (0.00%)  0
Aspartate aminotransferase increased  10/69 (14.49%)  19 11/42 (26.19%)  15 14/54 (25.93%)  30
Blood bilirubin increased  8/69 (11.59%)  8 3/42 (7.14%)  3 3/54 (5.56%)  3
Cholesterol high  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Creatinine increased  2/69 (2.90%)  2 0/42 (0.00%)  0 1/54 (1.85%)  1
GGT increased  3/69 (4.35%)  3 3/42 (7.14%)  7 7/54 (12.96%)  19
Investigations - Other, specify  1/69 (1.45%)  1 1/42 (2.38%)  1 0/54 (0.00%)  0
Lipase increased  2/69 (2.90%)  2 7/42 (16.67%)  8 5/54 (9.26%)  5
Lymphocyte count decreased  0/69 (0.00%)  0 4/42 (9.52%)  4 0/54 (0.00%)  0
Neutrophil count decreased  44/69 (63.77%)  121 29/42 (69.05%)  82 36/54 (66.67%)  92
Platelet count decreased  30/69 (43.48%)  52 20/42 (47.62%)  37 22/54 (40.74%)  33
Serum amylase increased  0/69 (0.00%)  0 2/42 (4.76%)  2 2/54 (3.70%)  2
Weight gain  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Weight loss  5/69 (7.25%)  5 4/42 (9.52%)  5 1/54 (1.85%)  1
White blood cell decreased  19/69 (27.54%)  27 16/42 (38.10%)  34 18/54 (33.33%)  45
Metabolism and nutrition disorders       
Acidosis  2/69 (2.90%)  2 2/42 (4.76%)  2 2/54 (3.70%)  3
Alkalosis  1/69 (1.45%)  1 0/42 (0.00%)  0 1/54 (1.85%)  1
Anorexia  11/69 (15.94%)  13 8/42 (19.05%)  11 5/54 (9.26%)  5
Dehydration  1/69 (1.45%)  1 5/42 (11.90%)  5 3/54 (5.56%)  5
Glucose intolerance  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Hypercalcemia  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Hyperglycemia  18/69 (26.09%)  36 11/42 (26.19%)  12 9/54 (16.67%)  18
Hyperkalemia  9/69 (13.04%)  10 2/42 (4.76%)  3 3/54 (5.56%)  3
Hypernatremia  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Hyperuricemia  2/69 (2.90%)  2 4/42 (9.52%)  4 2/54 (3.70%)  2
Hypoalbuminemia  8/69 (11.59%)  11 8/42 (19.05%)  9 2/54 (3.70%)  3
Hypocalcemia  13/69 (18.84%)  18 4/42 (9.52%)  4 11/54 (20.37%)  15
Hypoglycemia  0/69 (0.00%)  0 0/42 (0.00%)  0 3/54 (5.56%)  3
Hypokalemia  25/69 (36.23%)  40 15/42 (35.71%)  18 14/54 (25.93%)  21
Hypomagnesemia  0/69 (0.00%)  0 1/42 (2.38%)  1 2/54 (3.70%)  2
Hyponatremia  12/69 (17.39%)  12 8/42 (19.05%)  10 8/54 (14.81%)  10
Hypophosphatemia  9/69 (13.04%)  10 2/42 (4.76%)  2 3/54 (5.56%)  3
Obesity  0/69 (0.00%)  0 1/42 (2.38%)  1 2/54 (3.70%)  7
Tumor lysis syndrome  2/69 (2.90%)  2 5/42 (11.90%)  5 1/54 (1.85%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  2/69 (2.90%)  2 1/42 (2.38%)  1 0/54 (0.00%)  0
Avascular necrosis  2/69 (2.90%)  3 2/42 (4.76%)  2 2/54 (3.70%)  9
Back pain  5/69 (7.25%)  5 3/42 (7.14%)  3 4/54 (7.41%)  4
Bone pain  1/69 (1.45%)  1 1/42 (2.38%)  1 0/54 (0.00%)  0
Generalized muscle weakness  3/69 (4.35%)  3 2/42 (4.76%)  3 0/54 (0.00%)  0
Muscle weakness left-sided  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Muscle weakness lower limb  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Myositis  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Neck pain  0/69 (0.00%)  0 0/42 (0.00%)  0 2/54 (3.70%)  2
Pain in extremity  3/69 (4.35%)  5 4/42 (9.52%)  5 3/54 (5.56%)  3
Nervous system disorders       
Abducens nerve disorder  1/69 (1.45%)  3 0/42 (0.00%)  0 0/54 (0.00%)  0
Ataxia  0/69 (0.00%)  0 1/42 (2.38%)  1 1/54 (1.85%)  1
Cerebrospinal fluid leakage  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Cognitive disturbance  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Depressed level of consciousness  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Dizziness  0/69 (0.00%)  0 2/42 (4.76%)  2 2/54 (3.70%)  3
Dysphasia  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Encephalopathy  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Headache  1/69 (1.45%)  1 7/42 (16.67%)  8 7/54 (12.96%)  7
Hypoglossal nerve disorder  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Intracranial hemorrhage  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Nervous system disorders - Other, specify  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Neuralgia  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Seizure  1/69 (1.45%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Syncope  0/69 (0.00%)  0 1/42 (2.38%)  1 1/54 (1.85%)  1
Tremor  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Vagus nerve disorder  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Vasovagal reaction  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Psychiatric disorders       
Agitation  1/69 (1.45%)  1 1/42 (2.38%)  1 1/54 (1.85%)  1
Anxiety  1/69 (1.45%)  2 0/42 (0.00%)  0 2/54 (3.70%)  2
Confusion  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Depression  2/69 (2.90%)  2 2/42 (4.76%)  2 0/54 (0.00%)  0
Insomnia  0/69 (0.00%)  0 1/42 (2.38%)  1 1/54 (1.85%)  1
Personality change  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Psychiatric disorders - Other, specify  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Suicidal ideation  1/69 (1.45%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Chronic kidney disease  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Reproductive system and breast disorders       
Perineal pain  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Reproductive system and breast disorders - Other, specify  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Uterine hemorrhage  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome  2/69 (2.90%)  2 1/42 (2.38%)  1 0/54 (0.00%)  0
Apnea  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Dyspnea  2/69 (2.90%)  2 0/42 (0.00%)  0 1/54 (1.85%)  1
Epistaxis  3/69 (4.35%)  5 1/42 (2.38%)  2 1/54 (1.85%)  1
Hypoxia  8/69 (11.59%)  10 3/42 (7.14%)  3 5/54 (9.26%)  5
Pharyngeal mucositis  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Pharyngolaryngeal pain  3/69 (4.35%)  3 0/42 (0.00%)  0 0/54 (0.00%)  0
Pleural effusion  6/69 (8.70%)  7 0/42 (0.00%)  0 1/54 (1.85%)  1
Pneumonitis  1/69 (1.45%)  1 1/42 (2.38%)  1 0/54 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  0/69 (0.00%)  0 1/42 (2.38%)  1 1/54 (1.85%)  1
Skin and subcutaneous tissue disorders       
Pain of skin  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Pruritus  1/69 (1.45%)  1 1/42 (2.38%)  1 0/54 (0.00%)  0
Purpura  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Rash maculo-papular  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Urticaria  0/69 (0.00%)  0 1/42 (2.38%)  1 0/54 (0.00%)  0
Vascular disorders       
Capillary leak syndrome  0/69 (0.00%)  0 0/42 (0.00%)  0 1/54 (1.85%)  1
Hematoma  1/69 (1.45%)  1 0/42 (0.00%)  0 0/54 (0.00%)  0
Hypertension  3/69 (4.35%)  3 1/42 (2.38%)  1 1/54 (1.85%)  1
Hypotension  4/69 (5.80%)  4 4/42 (9.52%)  5 3/54 (5.56%)  3
Vascular disorders - Other, specify  2/69 (2.90%)  2 0/42 (0.00%)  0 0/54 (0.00%)  0
1
Term from vocabulary, CTCv4
Data is not and never will be available for Outcome Measure 10, Relationship between PK and presence of antibodies.
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.
Must obtain sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00671034     History of Changes
Other Study ID Numbers: AALL07P4
NCI-2009-00317 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AALL07P4 ( Other Identifier: Children's Oncology Group )
CDR0000594340 ( Other Identifier: Clinical Trials.gov )
AALL07P4 ( Other Identifier: Children's Oncology Group )
AALL07P4 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: May 1, 2008
First Posted: May 2, 2008
Results First Submitted: January 9, 2017
Results First Posted: September 6, 2018
Last Update Posted: September 6, 2018