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Trial record 58 of 170 for:    "Acute Lymphocytic Leukemia" | "Etoposide"

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00381680
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : May 12, 2017
Last Update Posted : May 12, 2017
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 Childhood Acute Lymphoblastic Leukemia
L1 Childhood Acute Lymphoblastic Leukemia
L2 Childhood Acute Lymphoblastic Leukemia
Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia
Interventions Drug: vincristine sulfate
Drug: prednisone
Drug: doxorubicin hydrochloride
Drug: pegaspargase
Drug: cytarabine
Drug: methotrexate
Drug: dexamethasone
Drug: etoposide
Drug: cyclophosphamide
Drug: leucovorin calcium
Biological: filgrastim
Drug: asparaginase
Drug: mercaptopurine
Enrollment 275
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Regimen A: Standard Vincristine Dosing Regimen B: Randomized High Dose Vincristine Regimen
Hide Arm/Group Description Standard VCR dosing (1.5 mg/m^2, max 2 mg) Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
Period Title: Overall Study
Started 206 69
Completed 81 19
Not Completed 125 50
Reason Not Completed
Adverse Event             9             3
Death             10             7
Lost to Follow-up             3             2
Physician Decision             25             6
Withdrawal by Subject             3             1
Entry onto another COG Trial             1             2
Alternative Therapy             11             5
Secondary Malignancy             3             0
Delay initiation             1             0
Stem Cell Transplant             26             10
Relapse             18             9
Induction Failure             4             1
Progression             1             1
Other not otherwise specified             7             2
Ineligible             3             1
Arm/Group Title Regimen A: Standard Vincristine Dosing Arm B: Randomized High Dose Vincristine Regimen Total
Hide Arm/Group Description Standard VCR dosing (1.5 mg/m^2, max 2 mg) Intensive VCR dosing (2 mg/m^2, max 2.5 mg) Total of all reporting groups
Overall Number of Baseline Participants 206 69 275
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 206 participants 69 participants 275 participants
17.21  (5.20) 19.62  (4.84) 17.82  (5.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 69 participants 275 participants
Female
96
  46.6%
25
  36.2%
121
  44.0%
Male
110
  53.4%
44
  63.8%
154
  56.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 69 participants 275 participants
Hispanic or Latino
55
  26.7%
8
  11.6%
63
  22.9%
Not Hispanic or Latino
145
  70.4%
51
  73.9%
196
  71.3%
Unknown or Not Reported
6
   2.9%
10
  14.5%
16
   5.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 69 participants 275 participants
American Indian or Alaska Native
3
   1.5%
0
   0.0%
3
   1.1%
Asian
5
   2.4%
2
   2.9%
7
   2.5%
Native Hawaiian or Other Pacific Islander
1
   0.5%
0
   0.0%
1
   0.4%
Black or African American
12
   5.8%
3
   4.3%
15
   5.5%
White
157
  76.2%
55
  79.7%
212
  77.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
28
  13.6%
9
  13.0%
37
  13.5%
1.Primary Outcome
Title Event Free Survival. EFS
Hide Description Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).
Time Frame 3 years after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is limited to eligible patients on regimen A (Standard VCR dosing) who did not undergo SCT.
Arm/Group Title Regimen A: Standard Vincristine Dosing
Hide Arm/Group Description:
Standard VCR dosing (1.5 mg/m^2, max 2 mg)
Overall Number of Participants Analyzed 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants EFS at 3 yrs3
66.0
(58.0 to 74.0)
2.Secondary Outcome
Title Frequency and Severity of Adverse Effects
Hide Description Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.
Time Frame Up to 107 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The total number of patients for CC or CT genotype is 81 and for high-risk CEP72 genotype is 18. No related by arm data were provided.
Arm/Group Title All Patients
Hide Arm/Group Description:
This analysis looks at all eligible patients with CC or CT genotypes as well as all eligible patients with the high-risk CEP72 genotype (TT at rs924607).
Overall Number of Participants Analyzed 99
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
CC or CT genotype Number Analyzed 81 participants
17.3
(10.1 to 27.6)
High-risk CEP72 genotype (TT at rs924607) Number Analyzed 18 participants
44.4
(22.4 to 68.7)
3.Secondary Outcome
Title Gene Expression Profile
Hide Description Percent of unfavorable gene expression profile of early versus late marrow relapse.
Time Frame Up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The data were not collected due to the lack of funds.
Arm/Group Title Regimen A: Standard Vincristine Dosing Arm B: Randomized High Dose Vincristine Regimen
Hide Arm/Group Description:
Standard VCR dosing (1.5 mg/m^2, max 2 mg)
Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
Hide Description Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1
Time Frame End of Block 1 (35 days) of Induction therapy
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is limited to all eligible patients with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1.
Arm/Group Title Regimen A Regimen B
Hide Arm/Group Description:
Standard VCR dosing (1.5 mg/m^2, max 2 mg)
Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
Overall Number of Participants Analyzed 122 53
Measure Type: Number
Unit of Measure: percentage of participants
50.8 41.5
5.Secondary Outcome
Title Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
Hide Description Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3.
Time Frame End of Block 3 (105 days) of Induction therapy
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is limited to all eligible patients with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3.
Arm/Group Title Regimen A Regimen B
Hide Arm/Group Description:
Standard VCR dosing (1.5 mg/m^2, max 2mg)
Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
Overall Number of Participants Analyzed 70 27
Measure Type: Number
Unit of Measure: percentage of participants
81.4 88.9
6.Secondary Outcome
Title Event Free Survival (EFS)
Hide Description Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The percentage of patients (pts) who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months. Pts with MRD <0.01% at the end of Block 1 (MRD < 0.01% BL1); MRD >= 0.01% at the end of Block 1 (MRD>= 0.01% BL1); MRD < 0.01% at the end of Block 3 (MRD < 0.01% BL3);MRD >=0.01% at the end of Block 3.
Arm/Group Title Regimen A Regimen B
Hide Arm/Group Description:
Standard VCR dosing (1.5 mg/m^2, max 2mg)
Intensive VCR dosing (2 mg/m^2, max 2.5 mg)
Overall Number of Participants Analyzed 127 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
MRD < 0.01% BL1 Number Analyzed 62 participants 22 participants
88.5
(80.4 to 96.6)
77.3
(59.8 to 94.8)
MRD >= 0.01% BL1 Number Analyzed 60 participants 31 participants
60.0
(47.6 to 72.4)
46.2
(27.8 to 64.7)
MRD < 0.01% BL3 Number Analyzed 57 participants 24 participants
83.8
(74.0 to 93.5)
83.3
(68.4 to 98.2)
MRD >= 0.01% BL3 Number Analyzed 13 participants 3 participants
61.5
(35.1 to 88.0)
33.3
(0.0 to 86.7)
7.Secondary Outcome
Title Adjusted Event Free Survival
Hide Description Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT).
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis is limited to eligible patients on Standard VCR dosing who received matched related SCT, excluding patients who had events prior to receiving SCT. And those patients on Regimen A who did not undergo SCT, excluding patients who went off therapy prior to the adjusted starting time.
Arm/Group Title Regimen A: Standard Vincristine Dosing
Hide Arm/Group Description:
Standard VCR dosing (1.5 mg/m^2, max 2 mg)
Overall Number of Participants Analyzed 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: adjusted percentage of participants
Received SCT Number Analyzed 34 participants
82.2
(68.8 to 95.5)
Did not receive SCT Number Analyzed 118 participants
64.2
(55.3 to 73.1)
Time Frame [Not Specified]
Adverse Event Reporting Description Only eligible patients are included in the toxicity adverse events for both serious and other.
 
Arm/Group Title Regimen A: Standard Vincristine Dosing Arm B: Randomized High Dose Vincristine Regimen
Hide Arm/Group Description

See detailed description.

vincristine sulfate: Given IV

prednisone: Given PO

doxorubicin hydrochloride: Given IV

pegaspargase: Given IM

cytarabine: Given IT or IV

methotrexate: Given IT or IV

dexamethasone: Given PO

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV or PO

filgrastim: Given IV or SC

asparaginase: Given IM

mercaptopurine: Given PO

See detailed description. Closed to accrual as of 09/2010).

vincristine sulfate: Given IV

prednisone: Given PO

doxorubicin hydrochloride: Given IV

pegaspargase: Given IM

cytarabine: Given IT or IV

methotrexate: Given IT or IV

dexamethasone: Given PO

etoposide: Given IV

cyclophosphamide: Given IV

leucovorin calcium: Given IV or PO

filgrastim: Given IV or SC

asparaginase: Given IM

mercaptopurine: Given PO

All-Cause Mortality
Regimen A: Standard Vincristine Dosing Arm B: Randomized High Dose Vincristine Regimen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Regimen A: Standard Vincristine Dosing Arm B: Randomized High Dose Vincristine Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/203 (19.70%)      11/68 (16.18%)    
Blood and lymphatic system disorders     
Disseminated intravascular coagulation  1/203 (0.49%)  1 1/68 (1.47%)  1
Febrile neutropenia  4/203 (1.97%)  4 0/68 (0.00%)  0
Cardiac disorders     
Sinus tachycardia  2/203 (0.99%)  2 0/68 (0.00%)  0
Ventricular arrhythmia  1/203 (0.49%)  1 0/68 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1/203 (0.49%)  1 0/68 (0.00%)  0
Anal necrosis  1/203 (0.49%)  1 0/68 (0.00%)  0
Anal ulcer  1/203 (0.49%)  1 0/68 (0.00%)  0
General disorders     
Death NOS  15/203 (7.39%)  15 1/68 (1.47%)  1
Edema face  1/203 (0.49%)  1 0/68 (0.00%)  0
Fever  1/203 (0.49%)  1 0/68 (0.00%)  0
Multi-organ failure  2/203 (0.99%)  2 1/68 (1.47%)  1
Hepatobiliary disorders     
Hepatic failure  0/203 (0.00%)  0 1/68 (1.47%)  1
Infections and infestations     
Appendicitis  1/203 (0.49%)  1 0/68 (0.00%)  0
Catheter related infection  2/203 (0.99%)  2 0/68 (0.00%)  0
Infections and infestations - Other, specify  7/203 (3.45%)  9 6/68 (8.82%)  7
Lung infection  2/203 (0.99%)  2 1/68 (1.47%)  1
Meningitis  1/203 (0.49%)  1 0/68 (0.00%)  0
Mucosal infection  1/203 (0.49%)  1 0/68 (0.00%)  0
Sepsis  8/203 (3.94%)  8 1/68 (1.47%)  1
Upper respiratory infection  1/203 (0.49%)  1 0/68 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1/203 (0.49%)  1 0/68 (0.00%)  0
Aspartate aminotransferase increased  1/203 (0.49%)  1 0/68 (0.00%)  0
Blood bilirubin increased  2/203 (0.99%)  2 0/68 (0.00%)  0
Neutrophil count decreased  3/203 (1.48%)  3 1/68 (1.47%)  1
Platelet count decreased  3/203 (1.48%)  3 2/68 (2.94%)  2
White blood cell decreased  1/203 (0.49%)  1 0/68 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis  1/203 (0.49%)  1 0/68 (0.00%)  0
Dehydration  1/203 (0.49%)  1 0/68 (0.00%)  0
Hypernatremia  1/203 (0.49%)  1 0/68 (0.00%)  0
Hyponatremia  1/203 (0.49%)  1 0/68 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Leukemia secondary to oncology chemotherapy  2/203 (0.99%)  3 0/68 (0.00%)  0
Myelodysplastic syndrome  1/203 (0.49%)  1 1/68 (1.47%)  1
Treatment related secondary malignancy  1/203 (0.49%)  1 0/68 (0.00%)  0
Nervous system disorders     
Intracranial hemorrhage  0/203 (0.00%)  0 2/68 (2.94%)  2
Myelitis  1/203 (0.49%)  1 0/68 (0.00%)  0
Seizure  0/203 (0.00%)  0 1/68 (1.47%)  1
Stroke  1/203 (0.49%)  1 0/68 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1/203 (0.49%)  1 0/68 (0.00%)  0
Bronchopulmonary hemorrhage  2/203 (0.99%)  2 0/68 (0.00%)  0
Hypoxia  1/203 (0.49%)  1 0/68 (0.00%)  0
Pleural effusion  1/203 (0.49%)  1 0/68 (0.00%)  0
Pneumonitis  1/203 (0.49%)  1 0/68 (0.00%)  0
Pneumothorax  1/203 (0.49%)  1 0/68 (0.00%)  0
Respiratory failure  1/203 (0.49%)  1 0/68 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders - Other, specify  1/203 (0.49%)  1 0/68 (0.00%)  0
Vascular disorders     
Hypotension  4/203 (1.97%)  4 1/68 (1.47%)  1
Thromboembolic event  2/203 (0.99%)  2 0/68 (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%
Regimen A: Standard Vincristine Dosing Arm B: Randomized High Dose Vincristine Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   189/203 (93.10%)      66/68 (97.06%)    
Blood and lymphatic system disorders     
Anemia  51/203 (25.12%)  102 22/68 (32.35%)  40
Bone marrow hypocellular  1/203 (0.49%)  1 0/68 (0.00%)  0
Disseminated intravascular coagulation  1/203 (0.49%)  1 1/68 (1.47%)  1
Febrile neutropenia  127/203 (62.56%)  250 48/68 (70.59%)  89
Hemolysis  2/203 (0.99%)  2 0/68 (0.00%)  0
Leukocytosis  1/203 (0.49%)  1 0/68 (0.00%)  0
Cardiac disorders     
Cardiac arrest  1/203 (0.49%)  1 0/68 (0.00%)  0
Chest pain - cardiac  1/203 (0.49%)  1 0/68 (0.00%)  0
Heart failure  0/203 (0.00%)  0 1/68 (1.47%)  1
Left ventricular systolic dysfunction  4/203 (1.97%)  4 1/68 (1.47%)  1
Myocarditis  1/203 (0.49%)  1 0/68 (0.00%)  0
Sinus tachycardia  1/203 (0.49%)  1 0/68 (0.00%)  0
Wolff-Parkinson-White syndrome  1/203 (0.49%)  1 0/68 (0.00%)  0
Ear and labyrinth disorders     
Ear pain  1/203 (0.49%)  1 0/68 (0.00%)  0
Hearing impaired  1/203 (0.49%)  1 1/68 (1.47%)  1
Middle ear inflammation  0/203 (0.00%)  0 1/68 (1.47%)  1
Eye disorders     
Eye pain  1/203 (0.49%)  1 1/68 (1.47%)  2
Optic nerve disorder  1/203 (0.49%)  5 1/68 (1.47%)  1
Photophobia  2/203 (0.99%)  2 1/68 (1.47%)  1
Retinopathy  0/203 (0.00%)  0 1/68 (1.47%)  1
Gastrointestinal disorders     
Abdominal distension  1/203 (0.49%)  1 0/68 (0.00%)  0
Abdominal pain  14/203 (6.90%)  16 7/68 (10.29%)  11
Anal fistula  2/203 (0.99%)  2 0/68 (0.00%)  0
Anal mucositis  0/203 (0.00%)  0 1/68 (1.47%)  1
Anal pain  2/203 (0.99%)  2 1/68 (1.47%)  1
Anal ulcer  1/203 (0.49%)  1 0/68 (0.00%)  0
Ascites  1/203 (0.49%)  1 0/68 (0.00%)  0
Colitis  9/203 (4.43%)  10 1/68 (1.47%)  1
Constipation  2/203 (0.99%)  2 0/68 (0.00%)  0
Dental caries  1/203 (0.49%)  1 1/68 (1.47%)  1
Diarrhea  17/203 (8.37%)  18 11/68 (16.18%)  12
Duodenal hemorrhage  0/203 (0.00%)  0 1/68 (1.47%)  1
Duodenal perforation  0/203 (0.00%)  0 1/68 (1.47%)  1
Duodenal ulcer  0/203 (0.00%)  0 1/68 (1.47%)  1
Dysphagia  1/203 (0.49%)  1 0/68 (0.00%)  0
Enterocolitis  1/203 (0.49%)  1 0/68 (0.00%)  0
Esophageal pain  1/203 (0.49%)  1 0/68 (0.00%)  0
Esophagitis  1/203 (0.49%)  1 0/68 (0.00%)  0
Fecal incontinence  0/203 (0.00%)  0 1/68 (1.47%)  1
Gastric fistula  1/203 (0.49%)  1 0/68 (0.00%)  0
Gastritis  1/203 (0.49%)  1 0/68 (0.00%)  0
Ileus  1/203 (0.49%)  1 0/68 (0.00%)  0
Malabsorption  0/203 (0.00%)  0 1/68 (1.47%)  1
Mucositis oral  43/203 (21.18%)  53 17/68 (25.00%)  27
Nausea  7/203 (3.45%)  7 6/68 (8.82%)  7
Oral pain  3/203 (1.48%)  4 6/68 (8.82%)  9
Pancreatitis  10/203 (4.93%)  11 0/68 (0.00%)  0
Rectal hemorrhage  0/203 (0.00%)  0 1/68 (1.47%)  1
Rectal mucositis  1/203 (0.49%)  1 0/68 (0.00%)  0
Rectal pain  1/203 (0.49%)  1 1/68 (1.47%)  1
Rectal ulcer  1/203 (0.49%)  1 0/68 (0.00%)  0
Small intestinal mucositis  1/203 (0.49%)  1 1/68 (1.47%)  1
Stomach pain  1/203 (0.49%)  1 0/68 (0.00%)  0
Toothache  1/203 (0.49%)  1 0/68 (0.00%)  0
Typhlitis  6/203 (2.96%)  7 1/68 (1.47%)  1
Vomiting  15/203 (7.39%)  16 6/68 (8.82%)  6
General disorders     
Edema limbs  2/203 (0.99%)  2 0/68 (0.00%)  0
Facial pain  0/203 (0.00%)  0 1/68 (1.47%)  1
Fatigue  2/203 (0.99%)  2 1/68 (1.47%)  2
Fever  32/203 (15.76%)  37 4/68 (5.88%)  4
Flu like symptoms  0/203 (0.00%)  0 1/68 (1.47%)  1
General disorders and administration site conditions - Other, specify  1/203 (0.49%)  2 0/68 (0.00%)  0
Infusion related reaction  2/203 (0.99%)  2 0/68 (0.00%)  0
Irritability  1/203 (0.49%)  1 0/68 (0.00%)  0
Localized edema  1/203 (0.49%)  1 0/68 (0.00%)  0
Non-cardiac chest pain  2/203 (0.99%)  2 0/68 (0.00%)  0
Pain  9/203 (4.43%)  9 7/68 (10.29%)  7
Hepatobiliary disorders     
Hepatobiliary disorders - Other, specify  1/203 (0.49%)  1 0/68 (0.00%)  0
Portal hypertension  0/203 (0.00%)  0 1/68 (1.47%)  1
Immune system disorders     
Allergic reaction  5/203 (2.46%)  5 0/68 (0.00%)  0
Anaphylaxis  10/203 (4.93%)  12 7/68 (10.29%)  8
Immune system disorders - Other, specify  0/203 (0.00%)  0 1/68 (1.47%)  1
Infections and infestations     
Anorectal infection  3/203 (1.48%)  3 1/68 (1.47%)  1
Appendicitis  5/203 (2.46%)  5 0/68 (0.00%)  0
Appendicitis perforated  0/203 (0.00%)  0 1/68 (1.47%)  2
Bladder infection  3/203 (1.48%)  3 0/68 (0.00%)  0
Bone infection  2/203 (0.99%)  2 0/68 (0.00%)  0
Bronchial infection  3/203 (1.48%)  3 0/68 (0.00%)  0
Catheter related infection  30/203 (14.78%)  35 3/68 (4.41%)  4
Device related infection  1/203 (0.49%)  1 0/68 (0.00%)  0
Enterocolitis infectious  9/203 (4.43%)  9 5/68 (7.35%)  7
Eye infection  0/203 (0.00%)  0 1/68 (1.47%)  1
Hepatic infection  2/203 (0.99%)  2 1/68 (1.47%)  1
Infections and infestations - Other, specify  101/203 (49.75%)  207 47/68 (69.12%)  135
Joint infection  1/203 (0.49%)  1 0/68 (0.00%)  0
Lip infection  1/203 (0.49%)  1 0/68 (0.00%)  0
Lung infection  22/203 (10.84%)  27 7/68 (10.29%)  8
Lymph gland infection  1/203 (0.49%)  1 0/68 (0.00%)  0
Meningitis  1/203 (0.49%)  1 0/68 (0.00%)  0
Mucosal infection  5/203 (2.46%)  5 0/68 (0.00%)  0
Otitis media  4/203 (1.97%)  5 0/68 (0.00%)  0
Pancreas infection  1/203 (0.49%)  3 0/68 (0.00%)  0
Paronychia  3/203 (1.48%)  4 0/68 (0.00%)  0
Penile infection  1/203 (0.49%)  1 0/68 (0.00%)  0
Peripheral nerve infection  2/203 (0.99%)  2 0/68 (0.00%)  0
Pleural infection  2/203 (0.99%)  2 0/68 (0.00%)  0
Sepsis  25/203 (12.32%)  32 4/68 (5.88%)  4
Sinusitis  4/203 (1.97%)  5 2/68 (2.94%)  3
Skin infection  16/203 (7.88%)  16 2/68 (2.94%)  2
Soft tissue infection  2/203 (0.99%)  2 1/68 (1.47%)  1
Upper respiratory infection  9/203 (4.43%)  9 1/68 (1.47%)  1
Urinary tract infection  13/203 (6.40%)  17 3/68 (4.41%)  3
Wound infection  5/203 (2.46%)  6 1/68 (1.47%)  1
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications - Other, specify  1/203 (0.49%)  1 0/68 (0.00%)  0
Vascular access complication  1/203 (0.49%)  1 1/68 (1.47%)  1
Investigations     
Activated partial thromboplastin time prolonged  5/203 (2.46%)  5 4/68 (5.88%)  4
Alanine aminotransferase increased  79/203 (38.92%)  153 24/68 (35.29%)  43
Alkaline phosphatase increased  3/203 (1.48%)  5 0/68 (0.00%)  0
Aspartate aminotransferase increased  54/203 (26.60%)  74 18/68 (26.47%)  24
Blood bilirubin increased  15/203 (7.39%)  18 10/68 (14.71%)  10
Cholesterol high  4/203 (1.97%)  5 0/68 (0.00%)  0
Creatinine increased  4/203 (1.97%)  4 0/68 (0.00%)  0
Ejection fraction decreased  1/203 (0.49%)  1 0/68 (0.00%)  0
Fibrinogen decreased  8/203 (3.94%)  8 4/68 (5.88%)  4
GGT increased  12/203 (5.91%)  16 2/68 (2.94%)  4
INR increased  0/203 (0.00%)  0 1/68 (1.47%)  1
Investigations - Other, specify  2/203 (0.99%)  2 0/68 (0.00%)  0
Lipase increased  17/203 (8.37%)  19 4/68 (5.88%)  4
Lymphocyte count decreased  15/203 (7.39%)  34 5/68 (7.35%)  9
Neutrophil count decreased  127/203 (62.56%)  421 44/68 (64.71%)  152
Platelet count decreased  93/203 (45.81%)  201 32/68 (47.06%)  72
Serum amylase increased  11/203 (5.42%)  13 3/68 (4.41%)  4
Weight gain  1/203 (0.49%)  1 1/68 (1.47%)  1
Weight loss  3/203 (1.48%)  3 1/68 (1.47%)  1
White blood cell decreased  61/203 (30.05%)  174 25/68 (36.76%)  70
Metabolism and nutrition disorders     
Acidosis  1/203 (0.49%)  1 2/68 (2.94%)  3
Alkalosis  1/203 (0.49%)  1 0/68 (0.00%)  0
Anorexia  20/203 (9.85%)  23 10/68 (14.71%)  18
Dehydration  14/203 (6.90%)  16 7/68 (10.29%)  9
Glucose intolerance  1/203 (0.49%)  1 0/68 (0.00%)  0
Hypercalcemia  1/203 (0.49%)  1 1/68 (1.47%)  1
Hyperglycemia  26/203 (12.81%)  35 12/68 (17.65%)  13
Hyperkalemia  8/203 (3.94%)  9 2/68 (2.94%)  2
Hypermagnesemia  0/203 (0.00%)  0 1/68 (1.47%)  2
Hypernatremia  3/203 (1.48%)  3 0/68 (0.00%)  0
Hypertriglyceridemia  11/203 (5.42%)  17 2/68 (2.94%)  3
Hyperuricemia  2/203 (0.99%)  2 2/68 (2.94%)  2
Hypoalbuminemia  19/203 (9.36%)  21 7/68 (10.29%)  9
Hypocalcemia  20/203 (9.85%)  23 8/68 (11.76%)  15
Hypokalemia  63/203 (31.03%)  103 20/68 (29.41%)  35
Hypomagnesemia  2/203 (0.99%)  2 0/68 (0.00%)  0
Hyponatremia  31/203 (15.27%)  40 12/68 (17.65%)  15
Hypophosphatemia  20/203 (9.85%)  22 4/68 (5.88%)  4
Iron overload  0/203 (0.00%)  0 1/68 (1.47%)  1
Tumor lysis syndrome  0/203 (0.00%)  0 1/68 (1.47%)  1
Musculoskeletal and connective tissue disorders     
Avascular necrosis  1/203 (0.49%)  1 1/68 (1.47%)  1
Back pain  6/203 (2.96%)  6 5/68 (7.35%)  11
Bone pain  1/203 (0.49%)  1 5/68 (7.35%)  6
Buttock pain  1/203 (0.49%)  1 0/68 (0.00%)  0
Flank pain  1/203 (0.49%)  1 0/68 (0.00%)  0
Generalized muscle weakness  1/203 (0.49%)  1 1/68 (1.47%)  1
Muscle weakness lower limb  1/203 (0.49%)  1 0/68 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  1/203 (0.49%)  1 0/68 (0.00%)  0
Myalgia  4/203 (1.97%)  4 0/68 (0.00%)  0
Myositis  2/203 (0.99%)  2 0/68 (0.00%)  0
Neck pain  0/203 (0.00%)  0 1/68 (1.47%)  1
Pain in extremity  7/203 (3.45%)  7 7/68 (10.29%)  11
Nervous system disorders     
Ataxia  1/203 (0.49%)  1 1/68 (1.47%)  1
Depressed level of consciousness  0/203 (0.00%)  0 2/68 (2.94%)  2
Dizziness  2/203 (0.99%)  2 1/68 (1.47%)  1
Encephalopathy  2/203 (0.99%)  2 2/68 (2.94%)  3
Extrapyramidal disorder  0/203 (0.00%)  0 1/68 (1.47%)  1
Headache  5/203 (2.46%)  5 5/68 (7.35%)  9
Intracranial hemorrhage  1/203 (0.49%)  1 0/68 (0.00%)  0
Leukoencephalopathy  0/203 (0.00%)  0 1/68 (1.47%)  1
Nervous system disorders - Other, specify  0/203 (0.00%)  0 1/68 (1.47%)  1
Neuralgia  2/203 (0.99%)  2 2/68 (2.94%)  2
Paresthesia  1/203 (0.49%)  1 0/68 (0.00%)  0
Peripheral motor neuropathy  9/203 (4.43%)  11 7/68 (10.29%)  11
Peripheral sensory neuropathy  7/203 (3.45%)  15 10/68 (14.71%)  19
Reversible posterior leukoencephalopathy syndrome  2/203 (0.99%)  2 0/68 (0.00%)  0
Seizure  3/203 (1.48%)  3 0/68 (0.00%)  0
Syncope  7/203 (3.45%)  7 3/68 (4.41%)  3
Tremor  1/203 (0.49%)  1 1/68 (1.47%)  1
Trigeminal nerve disorder  0/203 (0.00%)  0 2/68 (2.94%)  2
Psychiatric disorders     
Agitation  0/203 (0.00%)  0 1/68 (1.47%)  1
Anxiety  1/203 (0.49%)  1 2/68 (2.94%)  2
Confusion  0/203 (0.00%)  0 2/68 (2.94%)  2
Depression  1/203 (0.49%)  1 4/68 (5.88%)  5
Hallucinations  1/203 (0.49%)  1 0/68 (0.00%)  0
Insomnia  2/203 (0.99%)  2 1/68 (1.47%)  1
Personality change  0/203 (0.00%)  0 1/68 (1.47%)  3
Psychosis  1/203 (0.49%)  1 0/68 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  6/203 (2.96%)  6 1/68 (1.47%)  1
Renal and urinary disorders - Other, specify  2/203 (0.99%)  2 2/68 (2.94%)  2
Renal calculi  2/203 (0.99%)  2 0/68 (0.00%)  0
Urinary incontinence  0/203 (0.00%)  0 1/68 (1.47%)  1
Urinary retention  0/203 (0.00%)  0 1/68 (1.47%)  1
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1/203 (0.49%)  1 0/68 (0.00%)  0
Aspiration  2/203 (0.99%)  2 0/68 (0.00%)  0
Atelectasis  1/203 (0.49%)  1 0/68 (0.00%)  0
Bronchopleural fistula  1/203 (0.49%)  1 0/68 (0.00%)  0
Bronchospasm  0/203 (0.00%)  0 1/68 (1.47%)  1
Cough  1/203 (0.49%)  1 1/68 (1.47%)  1
Dyspnea  3/203 (1.48%)  3 3/68 (4.41%)  3
Epistaxis  7/203 (3.45%)  7 0/68 (0.00%)  0
Hypoxia  20/203 (9.85%)  25 11/68 (16.18%)  14
Pharyngeal mucositis  2/203 (0.99%)  2 0/68 (0.00%)  0
Pharyngolaryngeal pain  1/203 (0.49%)  1 0/68 (0.00%)  0
Pleural effusion  1/203 (0.49%)  1 1/68 (1.47%)  1
Pleuritic pain  0/203 (0.00%)  0 1/68 (1.47%)  1
Pneumonitis  7/203 (3.45%)  7 3/68 (4.41%)  3
Pneumothorax  1/203 (0.49%)  1 1/68 (1.47%)  1
Pulmonary edema  1/203 (0.49%)  1 0/68 (0.00%)  0
Respiratory failure  4/203 (1.97%)  4 0/68 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  2/203 (0.99%)  2 2/68 (2.94%)  2
Skin and subcutaneous tissue disorders     
Pain of skin  0/203 (0.00%)  0 1/68 (1.47%)  1
Pruritus  1/203 (0.49%)  1 0/68 (0.00%)  0
Rash maculo-papular  3/203 (1.48%)  3 1/68 (1.47%)  1
Skin and subcutaneous tissue disorders - Other, specify  3/203 (1.48%)  3 0/68 (0.00%)  0
Skin ulceration  1/203 (0.49%)  1 1/68 (1.47%)  1
Urticaria  0/203 (0.00%)  0 1/68 (1.47%)  1
Social circumstances     
Social circumstances - Other, specify  1/203 (0.49%)  1 0/68 (0.00%)  0
Surgical and medical procedures     
Surgical and medical procedures - Other, specify  2/203 (0.99%)  2 0/68 (0.00%)  0
Vascular disorders     
Capillary leak syndrome  1/203 (0.49%)  1 0/68 (0.00%)  0
Hematoma  1/203 (0.49%)  1 0/68 (0.00%)  0
Hypertension  4/203 (1.97%)  5 5/68 (7.35%)  6
Hypotension  31/203 (15.27%)  36 9/68 (13.24%)  9
Thromboembolic event  8/203 (3.94%)  11 1/68 (1.47%)  1
Vascular disorders - Other, specify  2/203 (0.99%)  2 0/68 (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.
Must obtain prior Sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Childrens'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: NCT00381680     History of Changes
Other Study ID Numbers: AALL0433
NCI-2009-00306 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AALL0433 ( Other Identifier: Children's Oncology Group )
CDR0000495359 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: December 16, 2016
Results First Posted: May 12, 2017
Last Update Posted: May 12, 2017