Phase 2 study of induction and early consolidation therapy for acute lymphoblastic leukemia in children (TCCSG ALL L04-16).
Phase 2
- Conditions
- Acute Lymphoblastic Leukemia
- Registration Number
- JPRN-UMIN000001413
- Lead Sponsor
- Tokyo Children's Cancer Study Group
- Brief Summary
Interim analysis of the 150 patients. Complete remission rate at completion of early consolidation is estimated as 97%. No unexpected treatment toxicity was reported.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Symptomatic intracranial hemorrhage (2) Uncontroled infection, (3) Double cancer, Secondary leukemia, (4) Down syndrome, (5) Pregnant, lactating woman, (6) Inadequate functioning of the liver (ALT>200 and serum total bilirubin level > 1.5 mg/dL), kidneys (serum creatinine level >= 1.5 mg/dL), (7) cardiac dysfunction, pulmonary dysfunction
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of complete remission at the completion of early consolidation.
- Secondary Outcome Measures
Name Time Method 1.The complete remission induction rate 2.The frequency of therapy toxicity