Status:
COMPLETED
A Randomized Trial of Recombinant Humanized Anti-IL-2 Receptor Antibody (Daclizumab) Versus Antithymocyte Globulin (ATG) to Treat the Cytopenia of Myelodysplastic Syndrome (MDS)
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study will evaluate a new immunosupressive therapy, Daclizumab, and compare it with antithymocyte globulin (ATG) to treat cytopenia, that is, the deficiency of cellular elements of the blood, in ...
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 of RA, RARS \& RAEB sub-types including those previously treated with chemotherapy or experimental agents such as retinoids, Vitamin D, and growth factors
- 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
- thrombocytopenia (platelet count less than 50000/ul)
- OR
- neutropenia (absolute neutrophil count less than 500/ul).
- Off all other treatments (except G-CSF, and transfusion support and related medications) for at least four weeks. 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.
- ECOG performance status less than or equal to 2
- High or intermediate predicted probability of response
- EXCLUSION CRITERIA:
- MDS of FAB sub-group chronic myelomonocytic leukemia (CMML)
- Transformation to acute leukemia (FAB sub-group RAEB-T, ie, greater than 20% blasts in marrow aspirate)
- Hypoplastic marrow without one major or two minor criteria
- Treatment with growth factors (except for G-CSF) or cyclosporine within 4 weeks prior to entry to protocol
- Recent or current treatment (24 hours wash out period) with the herbal supplement Echinacea purpurea or Usnea barbata (Old Man's Beard)
- ECOG performance status of greater than 2
- Active uncontrolled infection (chronic or current clinically significant infection, including hepatitis B or C virus infection)
- Current pregnancy, or unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential
- Patients for whom bone marrow transplant is indicated as standard therapy (age less than fifty-five with a fully-matched sibling donor)
- Age less than 18 years
- Not able to understand the investigational nature of the study or give informed consent
- HIV positive patients
- Active malignant disease (excluding basal cell carcinoma)
- Serum creatinine greater than 2mg/dl
- Patients who are moribund or patients with concurrent hepatic, renal, cardiac, metabolic, or any disease of such severity that death within 3 months is likely
- Low predicted probability of response
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00072969
Start Date
November 1 2003
End Date
August 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892