NCT01015261

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

Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
PROCEDURE	Bone Marrow Transplantation	Allogenic Bone Marrow Transplantation
PROCEDURE	Chemotherapy	1. Cyclophosphamide 1200 mg/m2 D15 2. Daunorubicin 45 mg/m2 D15-D18 3. Vincristine 1 mg/m2 D15, D22 4. Dexamethasone 24 mg/d D12-D28

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-03-01
• Completion: 2010-09-01
• First posted: 2009-11-18
• Last updated: 2010-11-22

Locations

1 site across 1 country: Iran