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Trial record 61 of 325 for:    "Acute Lymphocytic Leukemia" | "Methotrexate"

Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)

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ClinicalTrials.gov Identifier: NCT00866307
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : December 7, 2016
Last Update Posted : March 15, 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: 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: pegaspargase
Drug: cytarabine
Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Drug: prednisone
Drug: dexamethasone
Drug: methotrexate
Drug: daunorubicin hydrochloride
Drug: mercaptopurine
Drug: thioguanine
Radiation: prophylactic cranial irradiation
Other: laboratory biomarker analysis
Enrollment 104
Recruitment Details Patients with newly diagnosed high-risk B-precursor acute lymphoblastic leukemia (ALL), no prior cytotoxic chemotherapy besides steroids and intrathecal cytarabine and WBC criteria: Age 1.00-9.99 years: WBC >= 50,000/uL; Age 10.00 – 30.99 years or prior steroid therapy or with testicular leukemia: Any WBC
Pre-assignment Details Patients with Day 29 Marrow counts >25% (M3) or pegaspargase contraindication go off therapy before risk stratification.
Arm/Group Title Induction Group A (High Risk-Average) Group B (High Risk-High)
Hide Arm/Group Description All Patients Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM) Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
Period Title: Induction
Started 104 0 0
Completed 84 0 0
Not Completed 20 0 0
Reason Not Completed
Adverse Event             5             0             0
Death             2             0             0
Physician Decision             5             0             0
Progressive Disease             1             0             0
Identification of Patients with Day 29 M             3             0             0
Inadequate cytognetic samples th             1             0             0
Improper post-induction consent             2             0             0
Study was closed at the time             1             0             0
Period Title: Consolidation/Maintenance
Started 0 54 30
Completed 0 45 14
Not Completed 0 9 16
Reason Not Completed
Adverse Event             0             0             8
Death             0             0             1
Physician Decision             0             3             2
Withdrawal by Subject             0             1             1
Development of 2nd malignant neoplasm             0             0             2
Recurrent leukemia following remission             0             3             1
Therapy error             0             1             0
Non-compliance             0             0             1
Patient moved to non-participating inst             0             1             0
Arm/Group Title Induction
Hide Arm/Group Description All Patients
Overall Number of Baseline Participants 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
<=18 years
96
  92.3%
Between 18 and 65 years
8
   7.7%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
Female
42
  40.4%
Male
62
  59.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
Hispanic or Latino
37
  35.6%
Not Hispanic or Latino
63
  60.6%
Unknown or Not Reported
4
   3.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
American Indian or Alaska Native
0
   0.0%
Asian
6
   5.8%
Native Hawaiian or Other Pacific Islander
2
   1.9%
Black or African American
7
   6.7%
White
68
  65.4%
More than one race
0
   0.0%
Unknown or Not Reported
21
  20.2%
1.Primary Outcome
Title AALL08P1 Safety Outcome
Hide Description Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.
Time Frame Consolidation through Delayed Intensification
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with High Risk-High (Group B) Acute Lymphoblastic Leukemia (ALL)
Arm/Group Title Group B (High Risk-High)
Hide Arm/Group Description:
Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(35.6 to 64.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group B (High Risk-High)
Comments Per protocol, percentage of high risk-High patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy is compared to a null fixed rate (<=73%). A 90% two-sided Agresti-Coull confidence interval will be constructed and the lower bound examined. Will reject null if lower bound of confidence interval is above 73%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Agresti-Coull Confidence Interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 50.0
Confidence Interval (2-Sided) 90%
35.6 to 64.4
Estimation Comments [Not Specified]
2.Primary Outcome
Title AALL08P1 Feasibility Outcome
Hide Description Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.
Time Frame Consolidation through Delayed Intensification
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with High Risk-high Acute Lymphoblastic Leukemia (ALL)
Arm/Group Title Group B (High Risk-High)
Hide Arm/Group Description:
Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
53.3
(38.7 to 67.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group B (High Risk-High)
Comments Per protocol, percentage receiving at least 8 doses is compared to a null fixed rate (<=42%). A 90% two-sided Agresti-Coull confidence interval will be constructed. Will reject null if lower bound of confidence interval is above 42%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Agresti-Coull Confidence Interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 53.3
Confidence Interval (2-Sided) 90%
38.7 to 67.4
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Induction Group A (High Risk-Average) Group B (High Risk-High)
Hide Arm/Group Description All Patients Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM). Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy.
All-Cause Mortality
Induction Group A (High Risk-Average) Group B (High Risk-High)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Induction Group A (High Risk-Average) Group B (High Risk-High)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/104 (9.62%)      1/54 (1.85%)      4/30 (13.33%)    
Blood and lymphatic system disorders       
Disseminated intravascular coagulation  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Cardiac disorders       
Cardiac arrest  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Cardiac disorders - Other, specify  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Gastrointestinal disorders       
Colitis  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Typhlitis  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
General disorders       
Multi-organ failure  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Hepatobiliary disorders       
Hepatic hemorrhage  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Infections and infestations       
Infections and infestations - Other, specify  4/104 (3.85%)  4 0/54 (0.00%)  0 2/30 (6.67%)  2
Investigations       
Alanine aminotransferase increased  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Blood bilirubin increased  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Fibrinogen decreased  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Investigations - Other, specify  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Platelet count decreased  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Nervous system disorders       
Depressed level of consciousness  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Dysphasia  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Intracranial hemorrhage  2/104 (1.92%)  2 0/54 (0.00%)  0 2/30 (6.67%)  2
Nervous system disorders - Other, specify  4/104 (3.85%)  6 1/54 (1.85%)  1 0/30 (0.00%)  0
Seizure  4/104 (3.85%)  4 1/54 (1.85%)  1 1/30 (3.33%)  1
Syncope  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders       
Bronchopulmonary hemorrhage  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Hypoxia  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Pneumonitis  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Vascular disorders       
Hypertension  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Hypotension  3/104 (2.88%)  3 0/54 (0.00%)  0 2/30 (6.67%)  2
Thromboembolic event  2/104 (1.92%)  2 0/54 (0.00%)  0 1/30 (3.33%)  1
1
Term from vocabulary, CTCv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Induction Group A (High Risk-Average) Group B (High Risk-High)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   97/104 (93.27%)      53/54 (98.15%)      30/30 (100.00%)    
Blood and lymphatic system disorders       
Anemia  32/104 (30.77%)  58 18/54 (33.33%)  35 11/30 (36.67%)  19
Blood and lymphatic system disorders - Other, specify  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Disseminated intravascular coagulation  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Febrile neutropenia  57/104 (54.81%)  130 38/54 (70.37%)  85 18/30 (60.00%)  44
Cardiac disorders       
Wolff-Parkinson-White syndrome  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Eye disorders       
Optic nerve disorder  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Papilledema  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Gastrointestinal disorders       
Abdominal pain  11/104 (10.58%)  12 8/54 (14.81%)  9 3/30 (10.00%)  3
Ascites  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Colitis  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Constipation  2/104 (1.92%)  2 1/54 (1.85%)  1 1/30 (3.33%)  1
Diarrhea  3/104 (2.88%)  3 2/54 (3.70%)  2 1/30 (3.33%)  1
Dysphagia  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Lower gastrointestinal hemorrhage  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Malabsorption  2/104 (1.92%)  2 2/54 (3.70%)  2 0/30 (0.00%)  0
Mucositis oral  10/104 (9.62%)  10 6/54 (11.11%)  6 4/30 (13.33%)  4
Nausea  3/104 (2.88%)  3 2/54 (3.70%)  2 0/30 (0.00%)  0
Oral pain  3/104 (2.88%)  3 2/54 (3.70%)  2 1/30 (3.33%)  1
Pancreatic necrosis  1/104 (0.96%)  2 1/54 (1.85%)  2 0/30 (0.00%)  0
Pancreatitis  7/104 (6.73%)  9 4/54 (7.41%)  6 2/30 (6.67%)  2
Toothache  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Typhlitis  3/104 (2.88%)  3 3/54 (5.56%)  3 0/30 (0.00%)  0
Upper gastrointestinal hemorrhage  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Vomiting  4/104 (3.85%)  4 4/54 (7.41%)  4 0/30 (0.00%)  0
General disorders       
Fatigue  2/104 (1.92%)  2 1/54 (1.85%)  1 1/30 (3.33%)  1
Fever  5/104 (4.81%)  5 4/54 (7.41%)  4 0/30 (0.00%)  0
Gait disturbance  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Pain  4/104 (3.85%)  4 2/54 (3.70%)  2 2/30 (6.67%)  2
Hepatobiliary disorders       
Hepatobiliary disorders - Other, specify  2/104 (1.92%)  2 1/54 (1.85%)  1 1/30 (3.33%)  1
Immune system disorders       
Allergic reaction  10/104 (9.62%)  11 7/54 (12.96%)  8 3/30 (10.00%)  3
Anaphylaxis  15/104 (14.42%)  17 9/54 (16.67%)  11 5/30 (16.67%)  5
Immune system disorders - Other, specify  4/104 (3.85%)  8 3/54 (5.56%)  7 1/30 (3.33%)  1
Infections and infestations       
Abdominal infection  2/104 (1.92%)  2 2/54 (3.70%)  2 0/30 (0.00%)  0
Anorectal infection  2/104 (1.92%)  2 2/54 (3.70%)  2 0/30 (0.00%)  0
Appendicitis perforated  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Bladder infection  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Bronchial infection  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Catheter related infection  4/104 (3.85%)  4 2/54 (3.70%)  2 2/30 (6.67%)  2
Enterocolitis infectious  6/104 (5.77%)  8 6/54 (11.11%)  8 0/30 (0.00%)  0
Esophageal infection  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Infections and infestations - Other, specify  62/104 (59.62%)  155 39/54 (72.22%)  98 17/30 (56.67%)  39
Infective myositis  1/104 (0.96%)  2 1/54 (1.85%)  2 0/30 (0.00%)  0
Kidney infection  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Lung infection  10/104 (9.62%)  16 7/54 (12.96%)  11 3/30 (10.00%)  5
Lymph gland infection  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Mucosal infection  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Nail infection  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Otitis media  2/104 (1.92%)  2 2/54 (3.70%)  2 0/30 (0.00%)  0
Sepsis  2/104 (1.92%)  2 0/54 (0.00%)  0 1/30 (3.33%)  1
Sinusitis  4/104 (3.85%)  4 4/54 (7.41%)  4 0/30 (0.00%)  0
Skin infection  5/104 (4.81%)  6 2/54 (3.70%)  2 2/30 (6.67%)  3
Upper respiratory infection  6/104 (5.77%)  7 3/54 (5.56%)  4 3/30 (10.00%)  3
Urinary tract infection  4/104 (3.85%)  9 3/54 (5.56%)  4 1/30 (3.33%)  5
Vaginal infection  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Wound infection  1/104 (0.96%)  4 0/54 (0.00%)  0 0/30 (0.00%)  0
Injury, poisoning and procedural complications       
Intraoperative gastrointestinal injury  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Vascular access complication  8/104 (7.69%)  11 6/54 (11.11%)  9 1/30 (3.33%)  1
Wound dehiscence  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Investigations       
Activated partial thromboplastin time prolonged  2/104 (1.92%)  3 2/54 (3.70%)  3 0/30 (0.00%)  0
Alanine aminotransferase increased  47/104 (45.19%)  100 28/54 (51.85%)  70 15/30 (50.00%)  25
Alkaline phosphatase increased  4/104 (3.85%)  4 3/54 (5.56%)  3 1/30 (3.33%)  1
Aspartate aminotransferase increased  23/104 (22.12%)  30 14/54 (25.93%)  20 7/30 (23.33%)  8
Blood bilirubin increased  19/104 (18.27%)  29 10/54 (18.52%)  15 6/30 (20.00%)  11
Cholesterol high  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Creatinine increased  2/104 (1.92%)  2 1/54 (1.85%)  1 1/30 (3.33%)  1
Fibrinogen decreased  11/104 (10.58%)  15 7/54 (12.96%)  11 3/30 (10.00%)  3
GGT increased  9/104 (8.65%)  9 1/54 (1.85%)  1 6/30 (20.00%)  6
INR increased  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Investigations - Other, specify  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Lipase increased  10/104 (9.62%)  13 5/54 (9.26%)  8 3/30 (10.00%)  3
Lymphocyte count decreased  2/104 (1.92%)  4 2/54 (3.70%)  4 0/30 (0.00%)  0
Neutrophil count decreased  72/104 (69.23%)  212 47/54 (87.04%)  144 21/30 (70.00%)  61
Pancreatic enzymes decreased  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Platelet count decreased  34/104 (32.69%)  70 20/54 (37.04%)  37 11/30 (36.67%)  22
Serum amylase increased  5/104 (4.81%)  6 3/54 (5.56%)  4 1/30 (3.33%)  1
Weight gain  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Weight loss  6/104 (5.77%)  8 4/54 (7.41%)  5 2/30 (6.67%)  3
White blood cell decreased  37/104 (35.58%)  102 22/54 (40.74%)  64 12/30 (40.00%)  33
Metabolism and nutrition disorders       
Anorexia  7/104 (6.73%)  8 3/54 (5.56%)  4 3/30 (10.00%)  3
Dehydration  4/104 (3.85%)  4 3/54 (5.56%)  3 1/30 (3.33%)  1
Glucose intolerance  5/104 (4.81%)  6 4/54 (7.41%)  5 1/30 (3.33%)  1
Hypercalcemia  1/104 (0.96%)  2 1/54 (1.85%)  2 0/30 (0.00%)  0
Hyperglycemia  24/104 (23.08%)  31 12/54 (22.22%)  18 8/30 (26.67%)  9
Hyperkalemia  8/104 (7.69%)  8 4/54 (7.41%)  4 3/30 (10.00%)  3
Hypermagnesemia  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Hypertriglyceridemia  3/104 (2.88%)  3 3/54 (5.56%)  3 0/30 (0.00%)  0
Hyperuricemia  2/104 (1.92%)  2 1/54 (1.85%)  1 1/30 (3.33%)  1
Hypoalbuminemia  9/104 (8.65%)  12 3/54 (5.56%)  3 3/30 (10.00%)  6
Hypocalcemia  11/104 (10.58%)  12 7/54 (12.96%)  8 3/30 (10.00%)  3
Hypokalemia  12/104 (11.54%)  16 6/54 (11.11%)  8 4/30 (13.33%)  6
Hyponatremia  20/104 (19.23%)  24 10/54 (18.52%)  13 7/30 (23.33%)  7
Hypophosphatemia  7/104 (6.73%)  7 1/54 (1.85%)  1 4/30 (13.33%)  4
Iron overload  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Obesity  2/104 (1.92%)  2 2/54 (3.70%)  2 0/30 (0.00%)  0
Tumor lysis syndrome  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  2/104 (1.92%)  2 1/54 (1.85%)  1 1/30 (3.33%)  1
Avascular necrosis  9/104 (8.65%)  22 7/54 (12.96%)  19 2/30 (6.67%)  3
Back pain  3/104 (2.88%)  3 2/54 (3.70%)  2 1/30 (3.33%)  1
Joint effusion  1/104 (0.96%)  2 1/54 (1.85%)  2 0/30 (0.00%)  0
Joint range of motion decreased  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Muscle weakness lower limb  3/104 (2.88%)  7 1/54 (1.85%)  4 1/30 (3.33%)  1
Neck pain  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Pain in extremity  9/104 (8.65%)  13 5/54 (9.26%)  6 3/30 (10.00%)  3
Soft tissue necrosis lower limb  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Soft tissue necrosis upper limb  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Nervous system disorders       
Abducens nerve disorder  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Arachnoiditis  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Ataxia  2/104 (1.92%)  3 2/54 (3.70%)  3 0/30 (0.00%)  0
Cerebrospinal fluid leakage  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Cognitive disturbance  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Concentration impairment  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Depressed level of consciousness  2/104 (1.92%)  2 1/54 (1.85%)  1 1/30 (3.33%)  1
Dizziness  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Dysphasia  2/104 (1.92%)  2 2/54 (3.70%)  2 0/30 (0.00%)  0
Encephalopathy  2/104 (1.92%)  2 1/54 (1.85%)  1 0/30 (0.00%)  0
Headache  4/104 (3.85%)  5 3/54 (5.56%)  4 1/30 (3.33%)  1
Ischemia cerebrovascular  2/104 (1.92%)  2 0/54 (0.00%)  0 2/30 (6.67%)  2
Leukoencephalopathy  4/104 (3.85%)  4 3/54 (5.56%)  3 1/30 (3.33%)  1
Neuralgia  2/104 (1.92%)  4 1/54 (1.85%)  2 1/30 (3.33%)  2
Oculomotor nerve disorder  2/104 (1.92%)  3 1/54 (1.85%)  2 1/30 (3.33%)  1
Peripheral motor neuropathy  20/104 (19.23%)  30 10/54 (18.52%)  13 9/30 (30.00%)  16
Peripheral sensory neuropathy  22/104 (21.15%)  31 13/54 (24.07%)  16 7/30 (23.33%)  12
Seizure  5/104 (4.81%)  5 4/54 (7.41%)  4 1/30 (3.33%)  1
Syncope  2/104 (1.92%)  2 1/54 (1.85%)  1 1/30 (3.33%)  1
Tremor  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Psychiatric disorders       
Agitation  4/104 (3.85%)  4 2/54 (3.70%)  2 0/30 (0.00%)  0
Anxiety  2/104 (1.92%)  3 2/54 (3.70%)  3 0/30 (0.00%)  0
Confusion  2/104 (1.92%)  2 1/54 (1.85%)  1 0/30 (0.00%)  0
Depression  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Hallucinations  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Insomnia  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Personality change  3/104 (2.88%)  4 2/54 (3.70%)  2 1/30 (3.33%)  2
Psychosis  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Suicidal ideation  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Renal and urinary disorders       
Renal and urinary disorders - Other, specify  1/104 (0.96%)  2 0/54 (0.00%)  0 0/30 (0.00%)  0
Urinary tract pain  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Reproductive system and breast disorders       
Uterine hemorrhage  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Cough  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Dyspnea  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Hypoxia  5/104 (4.81%)  5 3/54 (5.56%)  3 0/30 (0.00%)  0
Pharyngeal mucositis  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Pharyngolaryngeal pain  1/104 (0.96%)  1 0/54 (0.00%)  0 1/30 (3.33%)  1
Pleural effusion  4/104 (3.85%)  5 2/54 (3.70%)  2 2/30 (6.67%)  3
Pneumonitis  2/104 (1.92%)  2 2/54 (3.70%)  2 0/30 (0.00%)  0
Pneumothorax  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  1/104 (0.96%)  1 0/54 (0.00%)  0 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin ulceration  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Urticaria  1/104 (0.96%)  1 1/54 (1.85%)  1 0/30 (0.00%)  0
Vascular disorders       
Hypertension  7/104 (6.73%)  7 2/54 (3.70%)  2 4/30 (13.33%)  4
Hypotension  3/104 (2.88%)  3 2/54 (3.70%)  2 1/30 (3.33%)  1
Thromboembolic event  3/104 (2.88%)  3 3/54 (5.56%)  3 0/30 (0.00%)  0
Vascular disorders - Other, specify  2/104 (1.92%)  2 0/54 (0.00%)  0 0/30 (0.00%)  0
1
Term from vocabulary, CTCv4
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: NCT00866307     History of Changes
Other Study ID Numbers: AALL08P1
NCI-2009-01169 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AALL08P1 ( Other Identifier: Children's Oncology Group )
CDR0000636174 ( Other Identifier: ClinicalTrials.gov )
AALL08P1 ( Other Identifier: Children's Oncology Group )
AALL08P1 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: March 19, 2009
First Posted: March 20, 2009
Results First Submitted: August 1, 2016
Results First Posted: December 7, 2016
Last Update Posted: March 15, 2017