Status:
WITHDRAWN
To Determine the Role of Adding Campath-1H or ATG Given In-vivo in Addition to Fludarabine and Low Dose Busulfex on Outcome in Patients Treated With Reduced Intensity Conditioning
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Bayer
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Multi-institutional randomized phase III trial of a non-myeloablative preparative regimen with fludarabine and busulfex with or without anti-lymphocyte antibodies (monoclonal humanized Campath-1H admi...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of AML or MDS, with no lower or upper age limit:
- a) Induction failure
- b) First or subsequent remission
- c) Untreated first relapse
- Patients must have an HLA compatible donor willing and capable of donating peripheral blood stem cells (first choice) or bone marrow progenitor cells using conventional techniques and blood lymphocytes if indicated (HLA compatible defined as 5/6 or 6/6 matched related or 10/10 molecular matched unrelated donor (A,B,C,DR,DRB1).
Exclusion
- Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B antigenemia).
- Evidence of bone marrow disease.
- Unable to donate bone marrow or peripheral blood due to concurrent medical condition.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00226512
Start Date
July 1 2004
Last Update
April 8 2011
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120