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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01015261

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Procedure: Bone Marrow Transplantation Procedure: Chemotherapy	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bone Marrow Transplantation	Procedure: Bone Marrow Transplantation Allogenic Bone Marrow Transplantation
Active Comparator: Chemotherapy	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

Arm

Intervention/Treatment

Experimental: Bone Marrow Transplantation

Procedure: Bone Marrow Transplantation

Allogenic Bone Marrow Transplantation

Active Comparator: Chemotherapy

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

Outcome Measures

Primary Outcome Measures

Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient [1 year]

Secondary Outcome Measures

Overall Survival after BMT compare with chemotherapy. [1 year]
Disease Free Survival after BMT compare with chemotherapy [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology-Oncology & SCT Research Center	Tehran		Iran, Islamic Republic of	14114

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Chair: Ardeshir Ghavamzadeh, MD, Hematology-Oncology and SCT Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01015261

Other Study ID Numbers:

HORCSCT-0903

First Posted:

Nov 18, 2009

Last Update Posted:

Nov 22, 2010

Last Verified:

Nov 1, 2010

Keywords provided by , ,

Additional relevant MeSH terms:

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Study Results

No Results Posted as of Nov 22, 2010