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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Bone Marrow Transplantation
Chemotherapy
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring ALL, BMT, Chemotherapy, Allogenic

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Hematology-Oncology & SCT Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bone Marrow Transplantation

Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient

Secondary Outcome Measures

Overall Survival after BMT compare with chemotherapy.
Disease Free Survival after BMT compare with chemotherapy

Full Information

First Posted
November 17, 2009
Last Updated
November 19, 2010
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01015261
Brief Title
Allogenic Bone Marrow Transplantation (BMT) Compare With Cytoreduction and Chemotherapy in Acute Lymphoblastic Leukemia (ALL) Patients
Official Title
Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
ALL, BMT, Chemotherapy, Allogenic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bone Marrow Transplantation
Arm Type
Experimental
Arm Title
Chemotherapy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Bone Marrow Transplantation
Intervention Description
Allogenic Bone Marrow Transplantation
Intervention Type
Procedure
Intervention Name(s)
Chemotherapy
Intervention Description
Cyclophosphamide 1200 mg/m2 D15 Daunorubicin 45 mg/m2 D15-D18 Vincristine 1 mg/m2 D15, D22 Dexamethasone 24 mg/d D12-D28
Primary Outcome Measure Information:
Title
Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall Survival after BMT compare with chemotherapy.
Time Frame
1 year
Title
Disease Free Survival after BMT compare with chemotherapy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ardeshir Ghavamzadeh, MD
Organizational Affiliation
Hematology-Oncology and SCT Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hematology-Oncology & SCT Research Center
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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