Status:
UNKNOWN
Alemtuzumab and Low-Dose Cyclosporine in Treating Patients With Severe Aplastic Anemia or Acquired Marrow Failure
Lead Sponsor:
Federico II University
Conditions:
Nonmalignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Immunosuppressive therapies, such as alemtuzumab and cyclosporine, may improve bone marrow function and increase blood cell counts. Giving alemtuzumab together with cyclosporine may be an e...
Detailed Description
OBJECTIVES: Primary * Determine the safety of alemtuzumab and low-dose cyclosporine, as defined by occurrence of adverse effects, in patients with severe aplastic anemia or single lineage acquired m...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Severe or very severe aplastic anemia, as defined by the following criteria:
- Meets ≥ 2 of the following criteria:
- Absolute neutrophil count \< 0.5 x 10\^9/L (severe) or \< 0.2 x 10\^9/L (very severe)
- Platelet count \< 20 x 10\^9/L
- Reticulocyte count \< 20 x 10\^9/L
- Hypocellular bone marrow (\< 30% cellularity) without evidence of fibrosis or malignant cells
- Single lineage acquired marrow failure (e.g., pure red cell aplasia, agranulocytosis, amegakaryocytic thrombocytopenia)
- Paroxysmal nocturnal hemoglobinuria clone allowed
- Failed first-line therapy with antithymocyte globulin (ATG) and cyclosporine OR not eligible for ATG-based studies
- Failure is defined as lack of hematological response, requirement for chronic immunosuppressive treatment to sustain response, or relapse
- Not eligible for a low-risk stem cell transplantation
- No evidence of risky myelodysplastic syndromes (i.e., IPSS 3-4), as defined by the presence of marrow blast excess or karyotypic abnormalities, or other primitive marrow disease
- No history of constitutional aplastic anemia (e.g., Fanconi anemia or dyskeratosis congenita)
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Not pregnant or nursing
- No active malignant tumor within the past 5 years
- Transaminases ≤ 3 times upper limit of normal (ULN)
- Albumin ≥ 1.5 g/L
- Creatinine ≤ 3 times ULN
- No CMV viremia, as defined by positive PCR or pp65 test
- No cardiac failure (i.e., ejection fraction \< 35%)
- No other concurrent life-threatening disease (including HIV infection)
- PRIOR CONCURRENT THERAPY:
- No prior allogeneic stem cell transplantation
- At least 2 weeks since prior cyclosporine or filgrastim (G-CSF)
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00895739
Start Date
June 1 2006
Last Update
August 12 2013
Active Locations (1)
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1
Federico II University Medical School
Naples, Italy, 80131