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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01015261

Enrollment

Registered

2009-11-18

Start date

2008-10-31

Completion date

2010-09-30

Last updated

2010-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

ALL, BMT, Chemotherapy, Allogenic

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.

Interventions

PROCEDUREBone Marrow Transplantation

Allogenic Bone Marrow Transplantation

PROCEDUREChemotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient	1 year

Secondary

Measure	Time frame
Overall Survival after BMT compare with chemotherapy.	1 year
Disease Free Survival after BMT compare with chemotherapy	1 year

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026