Status:
UNKNOWN
Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma
Lead Sponsor:
Cancer Research UK
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy and monoclonal antibody therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting ...
Detailed Description
OBJECTIVES: Primary * Determine progression-free survival in patients with mantle cell lymphoma undergoing low-intensity allogeneic stem cell transplantation. Secondary * Determine overall surviva...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of mantle cell lymphoma
- No relapsed or progressive disease
- Achieved at least a partial remission following induction chemotherapy
- HLA-matched donor available
- Blood samples from both patient and donor available for chimerism studies
- No central nervous system involvement
- PATIENT CHARACTERISTICS:
- ECOG performance status 2-4
- Considered fit for transplant by treating physician
- Serum bilirubin ≤ 1.5 times upper limit of normal
- Alkaline phosphatase ≤ 2 times normal
- Creatinine clearance ≥ 50 mL/min
- Ejection fraction \> 50% (no inadequate cardiac function)
- Not pregnant or nursing
- Negative pregnancy test
- No symptomatic respiratory compromise
- No serious concurrent disease which would preclude allograft
- No known serological positivity for hepatitis B, hepatitis C, or HIV
- No history of a psychological illness or condition that would affect compliance
- No previous malignancy within the past 5 years except nonmelanoma skin tumors or stage 0 (in situ) cervical carcinoma
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00720447
Start Date
November 1 2008
Last Update
August 2 2013
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