Allogenic Bone Marrow Transplantation (BMT) Compare With Cytoreduction and Chemotherapy in Acute Lymphoblastic Leukemia (ALL) Patients
Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 17, 2009
CompletedFirst Posted
Study publicly available on registry
November 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedNovember 22, 2010
November 1, 2010
1.4 years
November 17, 2009
November 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient
1 year
Secondary Outcomes (2)
Overall Survival after BMT compare with chemotherapy.
1 year
Disease Free Survival after BMT compare with chemotherapy
1 year
Study Arms (2)
Bone Marrow Transplantation
EXPERIMENTALChemotherapy
ACTIVE COMPARATORInterventions
Allogenic Bone Marrow Transplantation
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 Criteria
You may qualify if:
- Diagnose of Acute lymphoblastic leukemia
- Age between 16 to 50 year
- New case of ALL
You may not qualify if:
- Primary CNS involvement
- Primary Testis involvement
- Previously treated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province, 14114, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ardeshir Ghavamzadeh, MD
Hematology-Oncology and SCT Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 17, 2009
First Posted
November 18, 2009
Study Start
October 1, 2008
Primary Completion
March 1, 2010
Study Completion
September 1, 2010
Last Updated
November 22, 2010
Record last verified: 2010-11