Status:
COMPLETED
A Pilot Study of Alemtuzumab (Campath[R]) in Patients With Myelodysplastic Syndrome
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18-72 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and effectiveness of a genetically engineered antibody, alemtuzumab (Campath\[R\]) on patients with myelodysplastic syndrome. MDS is made up of malignant stem cell ...
Detailed Description
Many bone marrow failure syndromes in humans are now recognized to result from immunological mechanisms. These diseases include aplastic anemia, pure red cell aplasia, and some types of myelodysplasia...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- MDS with WHO classification of RA, RARS, RCMD-RS, RCUD, and RCMD and RAEB-1 (all subtypes of MDS with the exception of RAEB 2, CMML, and MDS/MPN overlap)
- Anemia requiring transfusion support with at least one unit of packed red blood cells per month for greater than or equal to 2 months
- OR
- Anemia (hemoglobin less than 9 or a reticulocyte count less than 60,000)
- OR
- thrombocytopenia (platelet count less than 50000/ul)
- OR
- neutropenia (absolute neutrophil count less than 500/ul).
- Off all other treatments for MDS (except filgrastim (G-CSF), erythropoietin, and transfusion support and related medications) for at least four weeks. Filgrastim (G-CSF) can be used before, during and after the protocol treatment for patients with documented neutropenia (less than 500/Ul) as long as they meet the criteria for anemia and/or thrombocytopenia as stated above.
- Ages 18-72 (inclusive)
- EXCLUSION CRITERIA:
- Chronic myelomonocytic leukemia (CMML), MDS/MPN overlap, WHO RAEB-2
- Secondary MDS
- Failure to respond to prior therapy with ATG or ATG/CsA
- Prior therapy with combination chemotherapy
- Transformation to acute leukemia (FAB sub-group RAEB-T, i.e., greater than 20% blasts in marrow aspirate)
- Failure to discontinue the herbal supplements Echinacea purpurea or Usnea barbata (Old Man's Beard) within 2 weeks of enrollment.
- Active infection not adequately responding to appropriate therapy
- HIV positive patients
- Active malignant disease (excluding non-melanoma skin carcinoma)
- Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy or that death within 7-10 days is likely.
- Life expectancy less than 6 months
- Low predicted probability of response
- Previous hypersensitivity to alemtuzumab (Campath\[R\]) or its components
- Current pregnancy, or unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential
- Not able to understand the investigational nature of the study or give informed consent
Exclusion
Key Trial Info
Start Date :
July 21 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00217594
Start Date
July 21 2005
End Date
February 6 2017
Last Update
October 30 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892