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Trial record 23 of 67 for:    "Acute Lymphocytic Leukemia" | "Hydrocortisone"

Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00720109
Recruitment Status : Completed
First Posted : July 22, 2008
Results First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Childhood Acute Lymphoblastic Leukemia
Interventions Drug: Asparaginase
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Etoposide
Biological: Filgrastim
Drug: Hydrocortisone Sodium Succinate
Drug: Ifosfamide
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Methylprednisolone
Drug: Pegaspargase
Drug: Prednisone
Radiation: Radiation Therapy
Drug: Vincristine Sulfate
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) Standard-risk High-risk
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Asparaginase: Given IT

Cyclophosphamide: Given IV

Cytarabine: Given IT or IV

Dasatinib: Given PO

Daunorubicin Hydrochloride: Given IV

Dexamethasone: Given IV or PO

Etoposide: Given IV

Filgrastim: Given IV or SC

Hydrocortisone Sodium Succinate: Given IT

Ifosfamide: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given IV or PO

Mercaptopurine: Given PO

Methotrexate: Given IT, PO, or IV

Methylprednisolone: Given IV

Pegaspargase: Given IM

Prednisone: Given PO or IV

Radiation Therapy: Some patients undergo cranial RT

Vincristine Sulfate: Given IV

Based on Minimal Residual Disease, less than 1%. Based on Minimal Residual Disease, great than or equal to 1%.
Period Title: Induction Period
Started 63 0 0
Completed 57 0 0
Not Completed 6 0 0
Reason Not Completed
Did not meet eligibility criteria             3             0             0
Bone Marrow Transplant             2             0             0
Physician Decision             1             0             0
Period Title: Risk Stratification Period
Started 0 48 9
Completed 0 33 1
Not Completed 0 15 8
Reason Not Completed
Adverse Event             0             1             0
Physician Decision             0             2             1
Bone marrow transplant             0             9             7
Disease progression or relapse             0             2             0
Development of second malignant neoplasm             0             1             0
Arm/Group Title Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)
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Asparaginase: Given IT

Cyclophosphamide: Given IV

Cytarabine: Given IT or IV

Dasatinib: Given PO

Daunorubicin Hydrochloride: Given IV

Dexamethasone: Given IV or PO

Etoposide: Given IV

Filgrastim: Given IV or SC

Hydrocortisone Sodium Succinate: Given IT

Ifosfamide: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given IV or PO

Mercaptopurine: Given PO

Methotrexate: Given IT, PO, or IV

Methylprednisolone: Given IV

Pegaspargase: Given IM

Prednisone: Given PO or IV

Radiation Therapy: Some patients undergo cranial RT

Vincristine Sulfate: Given IV

Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
Since all patients were enrolled under induction therapy and later risk stratified, all patients are grouped under the treatment induction group, including the three ineligible patients.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
<=18 years
56
  88.9%
Between 18 and 65 years
7
  11.1%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
20
  31.7%
Male
43
  68.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Hispanic or Latino
10
  15.9%
Not Hispanic or Latino
52
  82.5%
Unknown or Not Reported
1
   1.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
American Indian or Alaska Native
2
   3.2%
Asian
3
   4.8%
Native Hawaiian or Other Pacific Islander
1
   1.6%
Black or African American
9
  14.3%
White
45
  71.4%
More than one race
3
   4.8%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
Hide Description Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed.
Time Frame At 3 years
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Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
Arm/Group Title Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) Standard-risk High-risk
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Asparaginase: Given IT

Cyclophosphamide: Given IV

Cytarabine: Given IT or IV

Dasatinib: Given PO

Daunorubicin Hydrochloride: Given IV

Dexamethasone: Given IV or PO

Etoposide: Given IV

Filgrastim: Given IV or SC

Hydrocortisone Sodium Succinate: Given IT

Ifosfamide: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given IV or PO

Mercaptopurine: Given PO

Methotrexate: Given IT, PO, or IV

Methylprednisolone: Given IV

Pegaspargase: Given IM

Prednisone: Given PO or IV

Radiation Therapy: Some patients undergo cranial RT

Vincristine Sulfate: Given IV

Based on Minimal Residual Disease, less than 1%.
Based on Minimal Residual Disease, great than or equal to 1%.
Overall Number of Participants Analyzed 60 48 9
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percent probability
79.8
(71.1 to 88.5)
83.2
(74.1 to 92.2)
66.7
(40.9 to 92.5)
2.Primary Outcome
Title Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
Hide Description Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay)
Time Frame Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)
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Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)
Arm/Group Title Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)
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Feasibility measured by DLT rates in safety phase, Toxicities define DLTs and are summarized and reviewed to assess feasibility of administering the combination therapy with dasatinib
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Pts with DLTs
1
3.Secondary Outcome
Title Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
Hide Description Percent of patients MRD Positive (MRD > 0.01%) at End of Induction.
Time Frame At the end of induction therapy (at 5 weeks)
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Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
Arm/Group Title Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) Standard-risk High-risk
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Asparaginase: Given IT

Cyclophosphamide: Given IV

Cytarabine: Given IT or IV

Dasatinib: Given PO

Daunorubicin Hydrochloride: Given IV

Dexamethasone: Given IV or PO

Etoposide: Given IV

Filgrastim: Given IV or SC

Hydrocortisone Sodium Succinate: Given IT

Ifosfamide: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given IV or PO

Mercaptopurine: Given PO

Methotrexate: Given IT, PO, or IV

Methylprednisolone: Given IV

Pegaspargase: Given IM

Prednisone: Given PO or IV

Radiation Therapy: Some patients undergo cranial RT

Vincristine Sulfate: Given IV

Based on Minimal Residual Disease, less than 1%.
Based on Minimal Residual Disease, great than or equal to 1%.
Overall Number of Participants Analyzed 59 48 9
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
40.7
(30.8 to 51.4)
29.2
(19.7 to 40.9)
100.0
(73.1 to 100.0)
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Statistical Analysis Overview Comparison Group Selection Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)
Comments The a priori plan was to compare MRD positivity rate with that on a prior study, AALL0031 (n=72 Cohorts 1-5 of AALL0031 with 71% MRD positive). Out of 59 patients with end-Induction MRD on AALL0622, 40.7% were MRD positive. Per protocol, rates will be compared with a 2 sample Z-test of proportions, 1-sided test, alpha=5%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments Chi-squared test equivalent to Z-test of proportions.
Method of Estimation Estimation Parameter Percentage
Estimated Value 40.7
Confidence Interval (2-Sided) 90%
30.8 to 51.4
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
Hide Description A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used.
Time Frame At end of consolidation (at 11 weeks)
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Patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
Arm/Group Title Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) Standard-risk High-risk
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Asparaginase: Given IT

Cyclophosphamide: Given IV

Cytarabine: Given IT or IV

Dasatinib: Given PO

Daunorubicin Hydrochloride: Given IV

Dexamethasone: Given IV or PO

Etoposide: Given IV

Filgrastim: Given IV or SC

Hydrocortisone Sodium Succinate: Given IT

Ifosfamide: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given IV or PO

Mercaptopurine: Given PO

Methotrexate: Given IT, PO, or IV

Methylprednisolone: Given IV

Pegaspargase: Given IM

Prednisone: Given PO or IV

Radiation Therapy: Some patients undergo cranial RT

Vincristine Sulfate: Given IV

Based on Minimal Residual Disease, less than 1%.
Based on Minimal Residual Disease, great than or equal to 1%.
Overall Number of Participants Analyzed 57 48 9
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
10.5
(5.3 to 19.3)
0
(0.0 to 6.4)
66.7
(39.6 to 96.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.13
Comments [Not Specified]
Method Binomial Test
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage
Estimated Value 10.5
Confidence Interval (2-Sided) 90%
5.3 to 19.3
Estimation Comments The pre-specified threshold for the estimated percentage of MRD positivity at End Consolidation was set to 16%. Results show an upper bound on the (Agresti-Coull) confidence interval of 19.3%.
5.Secondary Outcome
Title Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
Hide Description An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death.
Time Frame From the time entry on study to first event or date of last follow-up, assessed up to 7 years
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Hide Analysis Population Description
Included in the analysis are two patients who received the drug therapy but were not risk classified.
Arm/Group Title Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) Standard-risk High-risk
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Asparaginase: Given IT

Cyclophosphamide: Given IV

Cytarabine: Given IT or IV

Dasatinib: Given PO

Daunorubicin Hydrochloride: Given IV

Dexamethasone: Given IV or PO

Etoposide: Given IV

Filgrastim: Given IV or SC

Hydrocortisone Sodium Succinate: Given IT

Ifosfamide: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given IV or PO

Mercaptopurine: Given PO

Methotrexate: Given IT, PO, or IV

Methylprednisolone: Given IV

Pegaspargase: Given IM

Prednisone: Given PO or IV

Radiation Therapy: Some patients undergo cranial RT

Vincristine Sulfate: Given IV

Based on Minimal Residual Disease, less than 1%.
Based on Minimal Residual Disease, great than or equal to 1%.
Overall Number of Participants Analyzed 60 48 9
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of patients
79.8
(71.1 to 88.5)
83.2
(74.1 to 92.2)
66.7
(40.9 to 92.5)
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.
 
Arm/Group Title Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) Standard-risk High-risk
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Asparaginase: Given IT

Cyclophosphamide: Given IV

Cytarabine: Given IT or IV

Dasatinib: Given PO

Daunorubicin Hydrochloride: Given IV

Dexamethasone: Given IV or PO

Etoposide: Given IV

Filgrastim: Given IV or SC

Hydrocortisone Sodium Succinate: Given IT

Ifosfamide: Given IV

Laboratory Biomarker Analysis: Correlative studies

Leucovorin Calcium: Given IV or PO

Mercaptopurine: Given PO

Methotrexate: Given IT, PO, or IV

Methylprednisolone: Given IV

Pegaspargase: Given IM

Prednisone: Given PO or IV

Radiation Therapy: Some patients undergo cranial RT

Vincristine Sulfate: Given IV

Based on Minimal Residual Disease, less than 1%. Based on Minimal Residual Disease, great than or equal to 1%.
All-Cause Mortality
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) Standard-risk High-risk
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) Standard-risk High-risk
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/60 (60.00%)      28/48 (58.33%)      7/9 (77.78%)    
Blood and lymphatic system disorders       
Anemia  3/60 (5.00%)  5 2/48 (4.17%)  3 1/9 (11.11%)  2
Febrile neutropenia  4/60 (6.67%)  4 3/48 (6.25%)  3 1/9 (11.11%)  1
Cardiac disorders       
Sinus tachycardia  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Eye disorders       
Blurred vision  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension  1/60 (1.67%)  1 0/48 (0.00%)  0 0/9 (0.00%)  0
Colitis  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Diarrhea  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Ileus  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Intra-abdominal hemorrhage  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Mucositis oral  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Nausea  1/60 (1.67%)  3 1/48 (2.08%)  3 0/9 (0.00%)  0
Oral pain  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Typhlitis  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
General disorders       
Edema limbs  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Fever  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Infusion related reaction  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Pain  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Immune system disorders       
Allergic reaction  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Anaphylaxis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Infections and infestations       
Catheter related infection  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Enterocolitis infectious  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Infections and infestations - Other, specify  7/60 (11.67%)  11 4/48 (8.33%)  6 2/9 (22.22%)  4
Periorbital infection  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Sepsis  2/60 (3.33%)  2 1/48 (2.08%)  1 1/9 (11.11%)  1
Upper respiratory infection  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Injury, poisoning and procedural complications       
Vascular access complication  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Investigations       
Activated partial thromboplastin time prolonged  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Alanine aminotransferase increased  16/60 (26.67%)  23 11/48 (22.92%)  17 5/9 (55.56%)  6
Alkaline phosphatase increased  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Aspartate aminotransferase increased  9/60 (15.00%)  11 6/48 (12.50%)  8 3/9 (33.33%)  3
Blood bilirubin increased  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Creatinine increased  2/60 (3.33%)  2 1/48 (2.08%)  1 1/9 (11.11%)  1
Electrocardiogram QT corrected interval prolonged  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
GGT increased  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
INR increased  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Lymphocyte count decreased  2/60 (3.33%)  3 1/48 (2.08%)  2 1/9 (11.11%)  1
Neutrophil count decreased  3/60 (5.00%)  6 2/48 (4.17%)  4 1/9 (11.11%)  2
Platelet count decreased  3/60 (5.00%)  5 2/48 (4.17%)  3 1/9 (11.11%)  2
White blood cell decreased  3/60 (5.00%)  6 2/48 (4.17%)  4 1/9 (11.11%)  2
Metabolism and nutrition disorders       
Anorexia  3/60 (5.00%)  3 2/48 (4.17%)  2 0/9 (0.00%)  0
Dehydration  4/60 (6.67%)  4 4/48 (8.33%)  4 0/9 (0.00%)  0
Hyperglycemia  1/60 (1.67%)  2 0/48 (0.00%)  0 1/9 (11.11%)  2
Hypoalbuminemia  5/60 (8.33%)  5 3/48 (6.25%)  3 2/9 (22.22%)  2
Hypocalcemia  3/60 (5.00%)  4 2/48 (4.17%)  2 1/9 (11.11%)  2
Hypokalemia  9/60 (15.00%)  12 6/48 (12.50%)  8 3/9 (33.33%)  4
Hyponatremia  5/60 (8.33%)  6 4/48 (8.33%)  4 1/9 (11.11%)  2
Hypophosphatemia  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Pain in extremity  1/60 (1.67%)  2 1/48 (2.08%)  2 0/9 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Treatment related secondary malignancy  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Nervous system disorders       
Dizziness  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Dysphasia  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Encephalopathy  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Headache  3/60 (5.00%)  3 3/48 (6.25%)  3 0/9 (0.00%)  0
Nervous system disorders - Other, specify  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Peripheral motor neuropathy  2/60 (3.33%)  3 1/48 (2.08%)  1 1/9 (11.11%)  2
Peripheral sensory neuropathy  2/60 (3.33%)  2 1/48 (2.08%)  1 1/9 (11.11%)  1
Seizure  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Psychiatric disorders       
Agitation  2/60 (3.33%)  2 1/48 (2.08%)  1 1/9 (11.11%)  1
Anxiety  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Confusion  2/60 (3.33%)  2 1/48 (2.08%)  1 1/9 (11.11%)  1
Personality change  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Renal and urinary disorders       
Chronic kidney disease  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Renal and urinary disorders - Other, specify  1/60 (1.67%)  2 1/48 (2.08%)  2 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Hypoxia  2/60 (3.33%)  2 1/48 (2.08%)  1 1/9 (11.11%)  1
Pneumonitis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders       
Erythema multiforme  1/60 (1.67%)  1 0/48 (0.00%)  0 0/9 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrome  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Pruritus  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Rash acneiform  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, spec  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Vascular disorders       
Hypertension  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Hypotension  4/60 (6.67%)  5 4/48 (8.33%)  5 0/9 (0.00%)  0
Superior vena cava syndrome  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Thromboembolic event  3/60 (5.00%)  3 3/48 (6.25%)  3 0/9 (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%
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) Standard-risk High-risk
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   59/60 (98.33%)      48/48 (100.00%)      8/9 (88.89%)    
Blood and lymphatic system disorders       
Anemia  23/60 (38.33%)  66 19/48 (39.58%)  61 3/9 (33.33%)  4
Febrile neutropenia  41/60 (68.33%)  148 36/48 (75.00%)  138 4/9 (44.44%)  9
Cardiac disorders       
Cardiac disorders - Other, specify  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Sinus tachycardia  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Ear and labyrinth disorders       
External ear pain  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Middle ear inflammation  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Endocrine disorders       
Adrenal insufficiency  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Gastrointestinal disorders       
Abdominal pain  7/60 (11.67%)  7 7/48 (14.58%)  7 0/9 (0.00%)  0
Anal mucositis  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Colitis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Constipation  3/60 (5.00%)  3 2/48 (4.17%)  2 1/9 (11.11%)  1
Diarrhea  9/60 (15.00%)  13 8/48 (16.67%)  12 0/9 (0.00%)  0
Dysphagia  1/60 (1.67%)  1 0/48 (0.00%)  0 0/9 (0.00%)  0
Esophagitis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Gastritis  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Gastrointestinal disorders - Other, specify  1/60 (1.67%)  2 1/48 (2.08%)  2 0/9 (0.00%)  0
Lower gastrointestinal hemorrhage  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Mucositis oral  17/60 (28.33%)  24 16/48 (33.33%)  23 0/9 (0.00%)  0
Nausea  10/60 (16.67%)  23 9/48 (18.75%)  22 1/9 (11.11%)  1
Oral pain  1/60 (1.67%)  2 1/48 (2.08%)  2 0/9 (0.00%)  0
Rectal mucositis  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Rectal pain  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Typhlitis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Vomiting  10/60 (16.67%)  16 10/48 (20.83%)  16 0/9 (0.00%)  0
General disorders       
Chills  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Edema limbs  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Fatigue  4/60 (6.67%)  4 2/48 (4.17%)  2 1/9 (11.11%)  1
Fever  4/60 (6.67%)  6 4/48 (8.33%)  6 0/9 (0.00%)  0
Pain  2/60 (3.33%)  3 2/48 (4.17%)  3 0/9 (0.00%)  0
Immune system disorders       
Allergic reaction  3/60 (5.00%)  3 2/48 (4.17%)  2 1/9 (11.11%)  1
Anaphylaxis  5/60 (8.33%)  5 3/48 (6.25%)  3 2/9 (22.22%)  2
Cytokine release syndrome  1/60 (1.67%)  2 1/48 (2.08%)  2 0/9 (0.00%)  0
Infections and infestations       
Appendicitis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Bladder infection  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Bone infection  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Catheter related infection  3/60 (5.00%)  8 2/48 (4.17%)  7 0/9 (0.00%)  0
Duodenal infection  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Enterocolitis infectious  6/60 (10.00%)  16 5/48 (10.42%)  15 1/9 (11.11%)  1
Infections and infestations - Other, specify  37/60 (61.67%)  99 34/48 (70.83%)  92 2/9 (22.22%)  6
Infective myositis  1/60 (1.67%)  2 1/48 (2.08%)  2 0/9 (0.00%)  0
Lung infection  5/60 (8.33%)  7 5/48 (10.42%)  7 0/9 (0.00%)  0
Mucosal infection  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Otitis media  5/60 (8.33%)  8 5/48 (10.42%)  8 0/9 (0.00%)  0
Peripheral nerve infection  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Sepsis  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Sinusitis  1/60 (1.67%)  2 1/48 (2.08%)  2 0/9 (0.00%)  0
Skin infection  9/60 (15.00%)  10 9/48 (18.75%)  10 0/9 (0.00%)  0
Small intestine infection  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Soft tissue infection  1/60 (1.67%)  2 1/48 (2.08%)  2 0/9 (0.00%)  0
Upper respiratory infection  3/60 (5.00%)  3 3/48 (6.25%)  3 0/9 (0.00%)  0
Urinary tract infection  3/60 (5.00%)  7 3/48 (6.25%)  7 0/9 (0.00%)  0
Vaginal infection  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Injury, poisoning and procedural complications       
Bruising  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Investigations       
Activated partial thromboplastin time prolonged  2/60 (3.33%)  2 1/48 (2.08%)  1 0/9 (0.00%)  0
Alanine aminotransferase increased  31/60 (51.67%)  119 29/48 (60.42%)  114 2/9 (22.22%)  5
Alkaline phosphatase increased  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Aspartate aminotransferase increased  20/60 (33.33%)  36 19/48 (39.58%)  35 1/9 (11.11%)  1
Blood bilirubin increased  5/60 (8.33%)  7 3/48 (6.25%)  5 2/9 (22.22%)  2
Creatinine increased  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Fibrinogen decreased  4/60 (6.67%)  4 4/48 (8.33%)  4 0/9 (0.00%)  0
GGT increased  3/60 (5.00%)  5 3/48 (6.25%)  5 0/9 (0.00%)  0
Lymphocyte count decreased  8/60 (13.33%)  8 6/48 (12.50%)  6 2/9 (22.22%)  2
Neutrophil count decreased  41/60 (68.33%)  144 38/48 (79.17%)  140 2/9 (22.22%)  3
Platelet count decreased  33/60 (55.00%)  83 29/48 (60.42%)  79 3/9 (33.33%)  3
White blood cell decreased  24/60 (40.00%)  80 20/48 (41.67%)  75 3/9 (33.33%)  4
Metabolism and nutrition disorders       
Acidosis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Anorexia  5/60 (8.33%)  11 5/48 (10.42%)  11 0/9 (0.00%)  0
Dehydration  4/60 (6.67%)  5 4/48 (8.33%)  5 0/9 (0.00%)  0
Glucose intolerance  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Hypercalcemia  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Hyperglycemia  13/60 (21.67%)  16 10/48 (20.83%)  13 3/9 (33.33%)  3
Hyperkalemia  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Hypoalbuminemia  8/60 (13.33%)  8 7/48 (14.58%)  7 1/9 (11.11%)  1
Hypocalcemia  9/60 (15.00%)  10 7/48 (14.58%)  8 2/9 (22.22%)  2
Hypoglycemia  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Hypokalemia  29/60 (48.33%)  57 27/48 (56.25%)  51 1/9 (11.11%)  5
Hyponatremia  14/60 (23.33%)  17 11/48 (22.92%)  14 3/9 (33.33%)  3
Hypophosphatemia  3/60 (5.00%)  7 2/48 (4.17%)  3 1/9 (11.11%)  4
Tumor lysis syndrome  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  3/60 (5.00%)  3 2/48 (4.17%)  2 0/9 (0.00%)  0
Avascular necrosis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Back pain  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Exostosis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorder - Ot  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Myalgia  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Pain in extremity  3/60 (5.00%)  3 1/48 (2.08%)  1 2/9 (22.22%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cy  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Nervous system disorders       
Acoustic nerve disorder NOS  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Cognitive disturbance  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Dizziness  1/60 (1.67%)  1 0/48 (0.00%)  0 0/9 (0.00%)  0
Encephalopathy  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Headache  5/60 (8.33%)  9 3/48 (6.25%)  7 1/9 (11.11%)  1
Hydrocephalus  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Leukoencephalopathy  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Nervous system disorders - Other, specify  3/60 (5.00%)  3 3/48 (6.25%)  3 0/9 (0.00%)  0
Peripheral motor neuropathy  8/60 (13.33%)  17 7/48 (14.58%)  16 1/9 (11.11%)  1
Peripheral sensory neuropathy  9/60 (15.00%)  17 9/48 (18.75%)  17 0/9 (0.00%)  0
Seizure  3/60 (5.00%)  3 2/48 (4.17%)  2 1/9 (11.11%)  1
Tremor  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Trigeminal nerve disorder  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Vasovagal reaction  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Psychiatric disorders       
Agitation  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Anxiety  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Confusion  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Depression  3/60 (5.00%)  3 1/48 (2.08%)  1 0/9 (0.00%)  0
Insomnia  2/60 (3.33%)  2 2/48 (4.17%)  2 0/9 (0.00%)  0
Personality change  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Psychosis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Epistaxis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Hypoxia  3/60 (5.00%)  3 3/48 (6.25%)  3 0/9 (0.00%)  0
Pharyngeal mucositis  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Pharyngolaryngeal pain  2/60 (3.33%)  2 1/48 (2.08%)  1 0/9 (0.00%)  0
Pneumonitis  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Ot  1/60 (1.67%)  1 0/48 (0.00%)  0 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders       
Bullous dermatitis  1/60 (1.67%)  2 1/48 (2.08%)  2 0/9 (0.00%)  0
Hyperhidrosis  1/60 (1.67%)  1 0/48 (0.00%)  0 1/9 (11.11%)  1
Palmar-plantar erythrodysesthesia syndrome  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Purpura  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Rash acneiform  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Rash maculo-papular  5/60 (8.33%)  8 4/48 (8.33%)  7 1/9 (11.11%)  1
Skin ulceration  1/60 (1.67%)  1 1/48 (2.08%)  1 0/9 (0.00%)  0
Vascular disorders       
Hypertension  5/60 (8.33%)  7 3/48 (6.25%)  3 2/9 (22.22%)  4
Hypotension  7/60 (11.67%)  8 7/48 (14.58%)  8 0/9 (0.00%)  0
1
Term from vocabulary, CTCv4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-241-1546
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00720109     History of Changes
Other Study ID Numbers: NCI-2009-00312
NCI-2009-00312 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000600217
COG-AALL0622
AALL0622
AALL0622 ( Other Identifier: Childrens Oncology Group )
AALL0622 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2008
First Posted: July 22, 2008
Results First Submitted: September 8, 2016
Results First Posted: October 7, 2016
Last Update Posted: October 7, 2016