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

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01015261
First received: November 17, 2009
Last updated: November 19, 2010
Last verified: November 2010
History of Changes
  Purpose

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 Intervention Phase
Acute Lymphoblastic Leukemia
 Procedure: Bone Marrow Transplantation
Procedure: Chemotherapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival after BMT compare with chemotherapy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Disease Free Survival after BMT compare with chemotherapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bone Marrow Transplantation Procedure: Bone Marrow Transplantation
Allogenic Bone Marrow Transplantation
Active Comparator: Chemotherapy 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

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015261

Locations
Iran, Islamic Republic of
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
  More Information

Additional Information:
Hematology-Oncology and Stem Cell Transplantation Research Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Mahdi Jalili MD / Hematology-Oncology and SCT Research Center, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01015261     History of Changes
Other Study ID Numbers: HORCSCT-0903
Study First Received: November 17, 2009
Last Updated: November 19, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
ALL
BMT
Chemotherapy
Allogenic

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013