Allogenic Bone Marrow Transplantation (BMT) Compare With Cytoreduction and Chemotherapy in Acute Lymphoblastic Leukemia (ALL) Patients
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Procedure: ChemotherapyProcedure: Bone Marrow Transplantation
- Registration Number
- NCT01015261
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Patients with newly diagnosed Acute lymphoblastic leukemia after providing consent, will be screened for eligibility. Eligible patients will be treated with Vincristine (1 mg/m2 at Day 1 and Day 8), Dexamethasone 24 mg/d day 1-15 and IT at Days 1, 4, 8 and 12. At day 14 patients will be randomized in two group. BMT group who have donor and Chemotherapy group who don't have suitable donor. BMT group treated with allogenic Bone Marrow Transplantation and Chemotherapy treated with Cyclophosphamide at day 15, Daunorubicin at day 15-18, Vincristine at day 15 and 22 and Dexamethasone at day 12-28 followed by standard chemotherapy. In BMT group patients will be received CNS radiotherapy at +100 day after transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Diagnose of Acute lymphoblastic leukemia
- Age between 16 to 50 year
- New case of ALL
- Primary CNS involvement
- Primary Testis involvement
- Previously treated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy Chemotherapy - Bone Marrow Transplantation Bone Marrow Transplantation -
- Primary Outcome Measures
Name Time Method Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient 1 year
- Secondary Outcome Measures
Name Time Method Overall Survival after BMT compare with chemotherapy. 1 year Disease Free Survival after BMT compare with chemotherapy 1 year
Trial Locations
- Locations (1)
Hematology-Oncology & SCT Research Center
🇮🇷Tehran, Iran, Islamic Republic of