E2993 Phase III Randomized Trial of Autologous And Allogeneic Bone Marrow Transplantation Versus Intensice Conventional Chemotherapy in Acute Lymphoblastic Leukemia in First Remission

Protocol Number: RMBMT-132

Major Objectives

• To compare CR duration and survival in ALL resulting from post-remission therapy with allogenic vs autologous SCT versus intensive conventional chemotherapy.
• To examine the differences in outcome for allogeneic SCT versus intensive conventional chemotherapy or autologous SCT.
• To examine, in a non-randomized study, post induction, the effect of 4 weeks of Imatinib therapy on patients with Ph+ ALL who have achieved a complete hematological remission (CR)
• To assess the benefit of an allogeneic stem cell transplant post treatment with Imatinib for those Ph+ patients with an allogeneic sibling matched donor, a matched unrelated donor or a related single haplotype matched donor. For those Ph+ patients who have no donor the benefit of an autologous stem cell transplant will be assessed.
• To assess the benefit of Imatinib therapy post transplant for all Ph+ autologous and Ph+ allogeneic patients.

Patient Selection

Inclusion Criteria:

• Diagnosis of ALL must be made upon bone marrow immunophenotyping with >25% lymphoblasts. Case with myeloid antigen expression, but unequivocal lymphoid immunophenotype, are eligible.
• Be previously untreated for malignancy. Previous therapy with corticosteroids alone will not exclude the patient.
• Be ≥ 15 and ≤ 65 years old.
• Have lab values obtained ≤ 1 week prior to registration. Serum direct bilirubin ≤ 2mg/dl and serum creatinine <2 mg/dl.
• Be HLA typed if ≤ 50 years of age during induction therapy phase or a written explanation for not undergoing HLA typing on the flow sheet for patients ≤ 50 years of age. Ph+ patients can be ≤ 65 years old.
• Have no intercurrect organ damage or medical problems that will jeopardize the outcome of therapy.
• Not be known to have HIV serum antibody positive.
• Have no myelodysplasia or other antecedent hematological disorder.
• Have no significant cardiac disease, or requiring antiarrhythmic for major ventricular dysrythmia, or antianginal medications for ischemic heart disease.
• Have given written signed, informed consent.