Allogenic Bone Marrow Transplantation (BMT) Compare With Cytoreduction and Chemotherapy in Acute Lymphoblastic Leukemia (ALL) Patients

Overview

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.

Full Title of Study: “Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2010

Interventions

  • Procedure: Bone Marrow Transplantation
    • Allogenic Bone Marrow Transplantation
  • Procedure: Chemotherapy
    • Cyclophosphamide 1200 mg/m2 D15 Daunorubicin 45 mg/m2 D15-D18 Vincristine 1 mg/m2 D15, D22 Dexamethasone 24 mg/d D12-D28

Arms, Groups and Cohorts

  • Experimental: Bone Marrow Transplantation
  • Active Comparator: Chemotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient
    • Time Frame: 1 year

Secondary Measures

  • Overall Survival after BMT compare with chemotherapy.
    • Time Frame: 1 year
  • Disease Free Survival after BMT compare with chemotherapy
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnose of Acute lymphoblastic leukemia – Age between 16 to 50 year – New case of ALL Exclusion Criteria:

  • Primary CNS involvement – Primary Testis involvement – Previously treated

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tehran University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Mahdi Jalili MD / Hematology-Oncology and SCT Research Center, Tehran University of Medical Sciences
  • Overall Official(s)
    • Ardeshir Ghavamzadeh, MD, Study Chair, Hematology-Oncology and SCT Research Center

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