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NCT01015261 Clinical Trial

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

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01015261
Other study ID # HORCSCT-0903
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received November 17, 2009
Last updated November 19, 2010
Start date October 2008
Est. completion date September 2010

Study information
Verified date November 2010
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Iran, Islamic Republic of Hematology-Oncology & SCT Research Center Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient 1 year No
Secondary Overall Survival after BMT compare with chemotherapy. 1 year No
Secondary Disease Free Survival after BMT compare with chemotherapy 1 year No
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