AALL0433, Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
As of amendment # 3, enrollment to Regimen B (intensified vincristine dose regimen) is closed and all newly enrolled eligible patients will be assigned to receive treatment as per Regimen A (standard vincristine dose regimen). Patients already enrolled on Regimen B will crossover to Regimen A, provided the patient has not experienced disease progression since enrollment onto AALL0433.
All patients will now receive standard VCR at 1.5 mg/m2/dose (max dose 2 mg) on Regimen A. All patients enrolled on AALL0433 will receive Induction Blocks 1-3. Those patients who are CNS-positive at relapse will receive Induction 3 before Induction 2. Patients with a suitable HLA-matched family donor are recommended to proceed to hematopoietic stem cell transplant upon recovery from the final induction block. HSCT is strongly recommended to be performed per COG companion protocol ASCT0431. Patients without a suitable matched family donor proceed to Intensification 1 after completion of Triple Induction. Patients with testicular involvement at relapse will not receive irradiation if testicular disease has resolved completely at the end of Induction I (biopsy may be needed for patients with equivocal clinical findings). Those patients with persistent testicular disease at end of Induction I, based on clinical and/or biopsy findings, will receive radiation during Induction 2 (2400 cGy to bilateral testes). Radiotherapy for those who are CNS positive at relapse will be given at the beginning of Maintenance (1800 cGy cranial). Patients with testicular and/or CNS disease who proceed to HSCT because of available donors are recommended to have radiotherapy given in conjunction with their preparative regimen for transplant.
Patients between 1 year and 29.99 years of age (inclusive) at the time of relapse. Patients with an initial intermediate-risk relapse of B-precursor ALL.Patients with adequate liver and heart function. All patients and/or their parent or legal guardian must sign a written informed consent. All institutional, FDA, and NCI requirements for human studies must be met.