- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01015261
Allogenic Bone Marrow Transplantation (BMT) Compare With Cytoreduction and Chemotherapy in Acute Lymphoblastic Leukemia (ALL) Patients
November 19, 2010 updated by: Tehran University of Medical Sciences
Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of, 14114
- Hematology-Oncology & SCT Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Chemotherapy
|
|
Experimental: Bone Marrow Transplantation
|
Allogenic Bone Marrow Transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival after BMT compare with chemotherapy.
Time Frame: 1 year
|
1 year
|
Disease Free Survival after BMT compare with chemotherapy
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ardeshir Ghavamzadeh, MD, Hematology-Oncology and SCT Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
November 17, 2009
First Submitted That Met QC Criteria
November 17, 2009
First Posted (Estimate)
November 18, 2009
Study Record Updates
Last Update Posted (Estimate)
November 22, 2010
Last Update Submitted That Met QC Criteria
November 19, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HORCSCT-0903
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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