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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:
ClinicalTrials.gov Identifier:
NCT01015261
First Posted: November 18, 2009
Last Update Posted: November 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tehran University of Medical Sciences
  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
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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Overall Survival after BMT compare with chemotherapy. [ Time Frame: 1 year ]
  • Disease Free Survival after BMT compare with chemotherapy [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: November 17, 2009
First Posted: November 18, 2009
Last Update Posted: November 22, 2010
Last Verified: November 2010

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

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