Antithymocyte Globulin and Cyclosporine to Treat Myelodysplasia
Myelodysplastic Syndrome
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring MDS, Immunosuppression, ATG, Cyclosporine, Myelodysplastic Syndrome
Eligibility Criteria
INCLUSION CRITERIA: MDS of refractory anemia (RA), refractory anemia with ring sideroblasts (RARS) & refractory anemia with excess blasts (RAEB) sub-types Off all other treatments (except G-CSF (granulocyte colony stimulating factor), 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. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less 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 ECOG performance status of greater than 2 Active uncontrolled infection Current pregnancy, or unwilling to take oral contraceptives 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 than18 years Not able to 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
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
Antithymocyte globulin & cyclosporine
Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.