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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Lymphoblastic Leukemia

Treatments: Procedure: Bone Marrow Transplantation; Procedure: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01015261

HORCSCT-0903

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Bone Marrow Transplantation

Experimental group

Treatment:

Procedure: Bone Marrow Transplantation

Chemotherapy

Active Comparator group

Treatment:

Procedure: Chemotherapy