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Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

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ClinicalTrials.gov Identifier: NCT00096135
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : August 6, 2015
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Biological: filgrastim
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: etoposide
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: pegaspargase
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Radiation: radiation therapy
Enrollment 168
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
Hide Arm/Group Description All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
Period Title: Overall Study
Started 126 42
Completed 63 27
Not Completed 63 15
Reason Not Completed
Physician Decision             20             4
Refusal of further protocol therapy             4             1
Progressive disease, Marrow,CNS, Relapse             22             7
Other, specify             15             3
Ineligible             2             0
Arm/Group Title CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy) Total
Hide Arm/Group Description All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. Total of all reporting groups
Overall Number of Baseline Participants 124 42 166
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 42 participants 166 participants
<=18 years
118
  95.2%
42
 100.0%
160
  96.4%
Between 18 and 65 years
6
   4.8%
0
   0.0%
6
   3.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 42 participants 166 participants
8.2  (4.8) 9.2  (3.2) 8.5  (4.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 42 participants 166 participants
Female
36
  29.0%
0
   0.0%
36
  21.7%
Male
88
  71.0%
42
 100.0%
130
  78.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 42 participants 166 participants
Hispanic or Latino
33
  26.6%
10
  23.8%
43
  25.9%
Not Hispanic or Latino
87
  70.2%
30
  71.4%
117
  70.5%
Unknown or Not Reported
4
   3.2%
2
   4.8%
6
   3.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 42 participants 166 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
8
   6.5%
1
   2.4%
9
   5.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
   8.1%
2
   4.8%
12
   7.2%
White
91
  73.4%
33
  78.6%
124
  74.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
15
  12.1%
6
  14.3%
21
  12.7%
1.Primary Outcome
Title Event-free Survival
Hide Description Monitoring of efficacy results will be performed in comparison with historical results.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The CNS-treatment cohort includes 126 patients with 120 CNS pre-B, 2 CNS+ITR pre-B and 4 T-AL. The primary analysis was restricted to CNS pre-B and ITR pre-B patients, respectively. Both CNS+ITR and T-ALL patients had to be excluded from the primary analysis. That is how we came to 120 in the CNS-treatment cohort for outcome analysis.
Arm/Group Title CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
Hide Arm/Group Description:
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
Overall Number of Participants Analyzed 120 40
Measure Type: Number
Unit of Measure: percentage of participants
64.9 70
Time Frame [Not Specified]
Adverse Event Reporting Description SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
 
Arm/Group Title CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
Hide Arm/Group Description All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
All-Cause Mortality
CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/124 (5.65%)      1/42 (2.38%)    
Blood and lymphatic system disorders     
Disseminated intravascular coagulation  1/124 (0.81%)  1 0/42 (0.00%)  0
Cardiac disorders     
Cardiac disorders - Other  1/124 (0.81%)  1 0/42 (0.00%)  0
General disorders     
Death NOS  1/124 (0.81%)  1 0/42 (0.00%)  0
Hepatobiliary disorders     
Hepatic failure  1/124 (0.81%)  1 0/42 (0.00%)  0
Infections and infestations     
Infections and infestations - Other  6/124 (4.84%)  7 1/42 (2.38%)  1
Lung infection  1/124 (0.81%)  1 0/42 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged  1/124 (0.81%)  1 0/42 (0.00%)  0
Alanine aminotransferase increased  1/124 (0.81%)  1 0/42 (0.00%)  0
Aspartate aminotransferase increased  1/124 (0.81%)  1 0/42 (0.00%)  0
Blood bilirubin increased  1/124 (0.81%)  1 0/42 (0.00%)  0
Fibrinogen decreased  1/124 (0.81%)  1 0/42 (0.00%)  0
GGT increased  1/124 (0.81%)  1 0/42 (0.00%)  0
INR increased  1/124 (0.81%)  1 0/42 (0.00%)  0
Platelet count decreased  1/124 (0.81%)  1 0/42 (0.00%)  0
White blood cell decreased  1/124 (0.81%)  1 0/42 (0.00%)  0
Metabolism and nutrition disorders     
Acidosis  1/124 (0.81%)  1 0/42 (0.00%)  0
Hyperglycemia  1/124 (0.81%)  1 0/42 (0.00%)  0
Hyponatremia  1/124 (0.81%)  1 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  2/124 (1.61%)  2 0/42 (0.00%)  0
Pneumonitis  2/124 (1.61%)  2 1/42 (2.38%)  1
Vascular disorders     
Thromboembolic event  1/124 (0.81%)  1 0/42 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   119/124 (95.97%)      41/42 (97.62%)    
Blood and lymphatic system disorders     
Anemia  52/124 (41.94%)  65 12/42 (28.57%)  15
Blood and lymphatic system disorders - Other  2/124 (1.61%)  2 0/42 (0.00%)  0
Disseminated intravascular coagulation  1/124 (0.81%)  1 0/42 (0.00%)  0
Febrile neutropenia  81/124 (65.32%)  86 27/42 (64.29%)  30
Cardiac disorders     
Sinus tachycardia  0/124 (0.00%)  0 1/42 (2.38%)  1
Ear and labyrinth disorders     
Middle ear inflammation  3/124 (2.42%)  3 0/42 (0.00%)  0
Eye disorders     
Extraocular muscle paresis  1/124 (0.81%)  1 0/42 (0.00%)  0
Eye disorders - Other  1/124 (0.81%)  1 1/42 (2.38%)  1
Photophobia  1/124 (0.81%)  1 0/42 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  7/124 (5.65%)  7 0/42 (0.00%)  0
Anal mucositis  2/124 (1.61%)  2 0/42 (0.00%)  0
Anal pain  1/124 (0.81%)  1 0/42 (0.00%)  0
Colitis  2/124 (1.61%)  2 0/42 (0.00%)  0
Constipation  1/124 (0.81%)  1 0/42 (0.00%)  0
Diarrhea  12/124 (9.68%)  12 5/42 (11.90%)  5
Dyspepsia  1/124 (0.81%)  1 0/42 (0.00%)  0
Esophagitis  1/124 (0.81%)  1 0/42 (0.00%)  0
Gastrointestinal disorders - Other  1/124 (0.81%)  1 0/42 (0.00%)  0
Ileus  1/124 (0.81%)  1 0/42 (0.00%)  0
Mucositis oral  15/124 (12.10%)  15 4/42 (9.52%)  4
Nausea  7/124 (5.65%)  7 2/42 (4.76%)  2
Oral pain  5/124 (4.03%)  5 1/42 (2.38%)  1
Pancreatitis  4/124 (3.23%)  4 2/42 (4.76%)  3
Rectal mucositis  0/124 (0.00%)  0 1/42 (2.38%)  1
Rectal pain  3/124 (2.42%)  3 0/42 (0.00%)  0
Stomach pain  1/124 (0.81%)  1 0/42 (0.00%)  0
Typhlitis  0/124 (0.00%)  0 1/42 (2.38%)  1
Vomiting  8/124 (6.45%)  8 0/42 (0.00%)  0
General disorders     
Death NOS  0/124 (0.00%)  0 1/42 (2.38%)  1
Fatigue  3/124 (2.42%)  3 0/42 (0.00%)  0
Fever  13/124 (10.48%)  13 6/42 (14.29%)  6
Flu like symptoms  2/124 (1.61%)  2 0/42 (0.00%)  0
General disorders and administration site conditions - Other  3/124 (2.42%)  3 0/42 (0.00%)  0
Multi-organ failure  1/124 (0.81%)  1 0/42 (0.00%)  0
Pain  6/124 (4.84%)  6 1/42 (2.38%)  1
Sudden death NOS  1/124 (0.81%)  1 0/42 (0.00%)  0
Hepatobiliary disorders     
Hepatic failure  1/124 (0.81%)  1 0/42 (0.00%)  0
Immune system disorders     
Allergic reaction  1/124 (0.81%)  1 1/42 (2.38%)  1
Anaphylaxis  11/124 (8.87%)  11 7/42 (16.67%)  7
Cytokine release syndrome  1/124 (0.81%)  1 1/42 (2.38%)  1
Immune system disorders - Other  1/124 (0.81%)  1 0/42 (0.00%)  0
Serum sickness  0/124 (0.00%)  0 1/42 (2.38%)  1
Infections and infestations     
Abdominal infection  1/124 (0.81%)  1 0/42 (0.00%)  0
Anorectal infection  2/124 (1.61%)  2 0/42 (0.00%)  0
Arteritis infective  1/124 (0.81%)  1 0/42 (0.00%)  0
Bladder infection  1/124 (0.81%)  1 0/42 (0.00%)  0
Bronchial infection  0/124 (0.00%)  0 1/42 (2.38%)  1
Catheter related infection  10/124 (8.06%)  10 3/42 (7.14%)  3
Enterocolitis infectious  6/124 (4.84%)  6 0/42 (0.00%)  0
Eye infection  1/124 (0.81%)  1 0/42 (0.00%)  0
Gum infection  1/124 (0.81%)  1 0/42 (0.00%)  0
Infections and infestations - Other  82/124 (66.13%)  90 23/42 (54.76%)  25
Joint infection  1/124 (0.81%)  1 0/42 (0.00%)  0
Lung infection  10/124 (8.06%)  10 2/42 (4.76%)  2
Meningitis  2/124 (1.61%)  2 0/42 (0.00%)  0
Mucosal infection  2/124 (1.61%)  2 0/42 (0.00%)  0
Otitis externa  4/124 (3.23%)  4 0/42 (0.00%)  0
Otitis media  1/124 (0.81%)  1 0/42 (0.00%)  0
Penile infection  1/124 (0.81%)  1 0/42 (0.00%)  0
Pharyngitis  2/124 (1.61%)  2 0/42 (0.00%)  0
Salivary gland infection  1/124 (0.81%)  1 0/42 (0.00%)  0
Sepsis  4/124 (3.23%)  4 1/42 (2.38%)  1
Sinusitis  2/124 (1.61%)  2 1/42 (2.38%)  1
Skin infection  4/124 (3.23%)  4 2/42 (4.76%)  2
Small intestine infection  1/124 (0.81%)  1 1/42 (2.38%)  1
Upper respiratory infection  4/124 (3.23%)  4 2/42 (4.76%)  2
Urinary tract infection  7/124 (5.65%)  7 1/42 (2.38%)  1
Wound infection  3/124 (2.42%)  3 0/42 (0.00%)  0
Injury, poisoning and procedural complications     
Dermatitis radiation  0/124 (0.00%)  0 2/42 (4.76%)  2
Fracture  1/124 (0.81%)  1 0/42 (0.00%)  0
Intraoperative venous injury  1/124 (0.81%)  1 0/42 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged  4/124 (3.23%)  4 0/42 (0.00%)  0
Alanine aminotransferase increased  64/124 (51.61%)  71 12/42 (28.57%)  14
Alkaline phosphatase increased  1/124 (0.81%)  1 0/42 (0.00%)  0
Aspartate aminotransferase increased  35/124 (28.23%)  35 4/42 (9.52%)  5
Blood bilirubin increased  7/124 (5.65%)  7 1/42 (2.38%)  1
Cholesterol high  2/124 (1.61%)  2 0/42 (0.00%)  0
Creatinine increased  2/124 (1.61%)  2 0/42 (0.00%)  0
Electrocardiogram QT corrected interval prolonged  0/124 (0.00%)  0 1/42 (2.38%)  1
Fibrinogen decreased  1/124 (0.81%)  1 1/42 (2.38%)  1
GGT increased  6/124 (4.84%)  6 0/42 (0.00%)  0
Investigations - Other  1/124 (0.81%)  1 0/42 (0.00%)  0
Lipase increased  9/124 (7.26%)  10 1/42 (2.38%)  1
Lymphocyte count decreased  3/124 (2.42%)  5 1/42 (2.38%)  2
Neutrophil count decreased  98/124 (79.03%)  130 33/42 (78.57%)  42
Platelet count decreased  73/124 (58.87%)  97 16/42 (38.10%)  23
Serum amylase increased  4/124 (3.23%)  4 0/42 (0.00%)  0
Weight gain  2/124 (1.61%)  2 1/42 (2.38%)  1
White blood cell decreased  63/124 (50.81%)  93 14/42 (33.33%)  19
Metabolism and nutrition disorders     
Anorexia  5/124 (4.03%)  5 3/42 (7.14%)  3
Dehydration  8/124 (6.45%)  8 6/42 (14.29%)  6
Glucose intolerance  1/124 (0.81%)  1 0/42 (0.00%)  0
Hyperglycemia  9/124 (7.26%)  9 5/42 (11.90%)  7
Hyperkalemia  1/124 (0.81%)  1 0/42 (0.00%)  0
Hypertriglyceridemia  2/124 (1.61%)  2 1/42 (2.38%)  1
Hypoalbuminemia  3/124 (2.42%)  3 0/42 (0.00%)  0
Hypocalcemia  6/124 (4.84%)  6 0/42 (0.00%)  0
Hypoglycemia  1/124 (0.81%)  1 0/42 (0.00%)  0
Hypokalemia  30/124 (24.19%)  35 9/42 (21.43%)  9
Hypomagnesemia  1/124 (0.81%)  1 0/42 (0.00%)  0
Hyponatremia  12/124 (9.68%)  12 3/42 (7.14%)  3
Hypophosphatemia  4/124 (3.23%)  4 1/42 (2.38%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1/124 (0.81%)  1 0/42 (0.00%)  0
Avascular necrosis  3/124 (2.42%)  3 0/42 (0.00%)  0
Back pain  6/124 (4.84%)  6 0/42 (0.00%)  0
Bone pain  3/124 (2.42%)  3 1/42 (2.38%)  1
Muscle weakness lower limb  1/124 (0.81%)  1 0/42 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other  1/124 (0.81%)  1 0/42 (0.00%)  0
Myalgia  2/124 (1.61%)  2 0/42 (0.00%)  0
Myositis  1/124 (0.81%)  1 0/42 (0.00%)  0
Neck pain  0/124 (0.00%)  0 1/42 (2.38%)  1
Pain in extremity  5/124 (4.03%)  5 3/42 (7.14%)  3
Nervous system disorders     
Ataxia  1/124 (0.81%)  1 0/42 (0.00%)  0
Cognitive disturbance  1/124 (0.81%)  1 0/42 (0.00%)  0
Depressed level of consciousness  1/124 (0.81%)  1 0/42 (0.00%)  0
Dizziness  1/124 (0.81%)  1 1/42 (2.38%)  1
Dysphasia  1/124 (0.81%)  1 0/42 (0.00%)  0
Headache  7/124 (5.65%)  7 0/42 (0.00%)  0
Memory impairment  1/124 (0.81%)  1 0/42 (0.00%)  0
Neuralgia  1/124 (0.81%)  1 0/42 (0.00%)  0
Peripheral motor neuropathy  9/124 (7.26%)  9 2/42 (4.76%)  2
Peripheral sensory neuropathy  8/124 (6.45%)  8 3/42 (7.14%)  3
Seizure  2/124 (1.61%)  2 0/42 (0.00%)  0
Sinus pain  1/124 (0.81%)  1 0/42 (0.00%)  0
Syncope  1/124 (0.81%)  1 0/42 (0.00%)  0
Psychiatric disorders     
Agitation  1/124 (0.81%)  1 1/42 (2.38%)  1
Anxiety  1/124 (0.81%)  1 0/42 (0.00%)  0
Confusion  1/124 (0.81%)  1 0/42 (0.00%)  0
Depression  2/124 (1.61%)  2 0/42 (0.00%)  0
Insomnia  1/124 (0.81%)  1 0/42 (0.00%)  0
Personality change  2/124 (1.61%)  2 1/42 (2.38%)  1
Psychosis  1/124 (0.81%)  1 0/42 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  2/124 (1.61%)  2 0/42 (0.00%)  0
Proteinuria  1/124 (0.81%)  1 0/42 (0.00%)  0
Renal calculi  0/124 (0.00%)  0 1/42 (2.38%)  1
Urinary tract obstruction  1/124 (0.81%)  1 0/42 (0.00%)  0
Urinary tract pain  1/124 (0.81%)  1 0/42 (0.00%)  0
Reproductive system and breast disorders     
Penile pain  1/124 (0.81%)  1 0/42 (0.00%)  0
Perineal pain  1/124 (0.81%)  1 0/42 (0.00%)  0
Vaginal inflammation  1/124 (0.81%)  1 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Apnea  0/124 (0.00%)  0 1/42 (2.38%)  1
Bronchopulmonary hemorrhage  1/124 (0.81%)  1 0/42 (0.00%)  0
Cough  4/124 (3.23%)  4 0/42 (0.00%)  0
Dyspnea  0/124 (0.00%)  0 1/42 (2.38%)  1
Epistaxis  3/124 (2.42%)  3 0/42 (0.00%)  0
Hiccups  1/124 (0.81%)  1 0/42 (0.00%)  0
Hypoxia  4/124 (3.23%)  4 1/42 (2.38%)  1
Pharyngeal mucositis  1/124 (0.81%)  1 0/42 (0.00%)  0
Pharyngolaryngeal pain  1/124 (0.81%)  1 0/42 (0.00%)  0
Pneumonitis  7/124 (5.65%)  7 2/42 (4.76%)  2
Respiratory, thoracic and mediastinal disorders - Other  3/124 (2.42%)  3 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pain of skin  1/124 (0.81%)  1 1/42 (2.38%)  1
Purpura  1/124 (0.81%)  1 0/42 (0.00%)  0
Rash acneiform  1/124 (0.81%)  1 0/42 (0.00%)  0
Rash maculo-papular  1/124 (0.81%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders - Other  2/124 (1.61%)  2 0/42 (0.00%)  0
Vascular disorders     
Capillary leak syndrome  0/124 (0.00%)  0 1/42 (2.38%)  1
Hypertension  2/124 (1.61%)  2 0/42 (0.00%)  0
Hypotension  4/124 (3.23%)  4 3/42 (7.14%)  3
Thromboembolic event  1/124 (0.81%)  1 3/42 (7.14%)  3
Vascular disorders - Other  1/124 (0.81%)  1 0/42 (0.00%)  0
The COG SDC reviewed the NLM notification related to ct.gov AE/SAE reporting. The information in ‘Additional Description’ is accurate with respect to data supplied to ct.gov.COG plans to submit data AE/SAE data consistent with the text in this field.
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: 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: NCT00096135     History of Changes
Other Study ID Numbers: AALL02P2
COG-AALL02P2 ( Other Identifier: Children's Oncology Group )
NCI-2011-01623 ( Other Identifier: NCI Trial Identifier )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: July 10, 2015
Results First Posted: August 6, 2015
Last Update Posted: March 21, 2017