Status:
UNKNOWN
Fludarabine Phosphate, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed Hodgkin Lymphoma
Lead Sponsor:
Cancer Research UK
Conditions:
Lymphoma
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, mo...
Detailed Description
OBJECTIVES: * To document the toxicity, feasibility, and survival after reduced-intensity conditioning followed by allogeneic hematopoietic stem cell transplantation from a matched sibling donor in p...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed diagnosis of Hodgkin lymphoma, meeting all of the following criteria:
- Achieved partial or complete remission (using standard criteria) after salvage chemotherapy
- Relapsed after first remission with residual fludeoxyglucose F 18-avid lesions
- Available HLA-matched sibling donor
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Creatinine clearance ≥ 50 mL/min (measured by EDTA clearance or 24-hour urine collection)
- Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2 times ULN
- LVEF ≥ 40%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months (or 3 months for women) after completion of study therapy
- No other malignancy within the past 5 years except for nonmelanoma skin tumors or stage 0 (in situ) cervical carcinoma
- No HIV positivity
- No symptomatic respiratory compromise
- No concurrent serious medical condition that would preclude transplantation
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior high-dose therapy or allograft
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00907036
Start Date
July 1 2009
Last Update
August 2 2013
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