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

NCT01015261 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-11-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Ardeshir Ghavamzadeh, MD · Hematology-Oncology and SCT Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-03-31
Completion
2010-09-30

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015261 on ClinicalTrials.gov