Status:
COMPLETED
Fludarabine, Busulfan, and Antilymphocyte Globulin Followed by Donor Stem Cell Transplant in Treating Older Patients With Hematological Cancer
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Chronic Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
56-74 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the p...
Detailed Description
OBJECTIVES: Primary * To assess non-relapse or progression-related mortality at 1 year in patients over 55 with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantati...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of a hematological malignancy
- Candidate for an allogeneic hematopoietic stem cell transplantation
- Available HLA-identical related donor
- PATIENT CHARACTERISTICS:
- WHO performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Life expectancy \> 6 months
- LVEF ≥ 40%
- DLCO ≥ 50%
- Creatinine clearance ≥ 30 mL/min
- Transaminases and/or bilirubin ≤ 2 times upper limit of normal (ULN)
- No other cancer within the past 5 years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No human T-cell leukemia virus type 1 positivity
- No HIV positivity
- No uncontrolled bacterial, viral, or fungal infection
- No contraindications to the study drugs
- No concurrent serious and uncontrolled disease
- PRIOR CONCURRENT THERAPY:
- At least 1 month since prior participation in a clinical trial
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00806767
Start Date
March 1 2007
Last Update
May 17 2011
Active Locations (1)
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1
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273