Status:
UNKNOWN
Carmustine, Etoposide, Cytarabine, Melphalan, and Alemtuzumab Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory 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 may also stop the patient's immune system from rejecting the donor's stem cells. Monoclonal...
Detailed Description
OBJECTIVES: * To document the toxicity and feasibility of reduced-intensity conditioning regimen comprising carmustine, etoposide, cytarabine, melphalan, and alemtuzumab followed by allogeneic hemato...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed diagnosis of Hodgkin lymphoma, meeting 1 of the following criteria:
- Refractory to initial multi-agent induction therapy and achieved less than a complete response to one line of salvage chemotherapy
- In first relapse and achieved less than a partial response to one line of salvage chemotherapy
- No progressive disease
- Must have an HLA-matched (≥ 9/10) sibling or unrelated donor available
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Creatinine clearance ≥ 50 mL/min
- 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 2-3 months after completion of study treatment
- No HIV positivity
- No other malignancy within the past 5 years, except for nonmelanoma skin cancer or stage 0 (in situ) cervical carcinoma
- No concurrent serious medical condition that would preclude an allograft
- No symptomatic respiratory compromise
- 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 :
47 Patients enrolled
Trial Details
Trial ID
NCT00908180
Start Date
July 1 2009
Last Update
August 2 2013
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