At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of MDS with refractory anemia (RA), refractory anemia with ring sideroblasts (RARS), or refractory anemia with excess blasts (RAEB) subtype
- ✓Off all other treatments (except G-CSF, transfusion, and related medications) for ≥4 weeks
- ✓ECOG performance status 0-2
- ✓High or intermediate predicted probability of response
- ✕MDS subtype CMML (chronic myelomonocytic leukemia)
- ✕Transformation to acute leukemia with >20% blasts in marrow
- ✕Hypoplastic marrow without adequate criteria for response
- ✕Prior growth factors (except G-CSF) or cyclosporine within 4 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Antithymocyte Globulin (ATG) and Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome (MDS)
In Brief
A Phase 2 clinical trial evaluating Antithymocyte globulin and Cyclosporine for Myelodysplastic Syndrome. Completed, enrolled 42 participants across 1 site.
Detailed Summary
This study will determine the safety and effectiveness of a combination of the immune-suppressing drugs antithymocyte globulin (ATG) and cyclosporine for treating myelodysplasia, a disorder of low blood cell counts. It will: evaluate whether this drug combination can increase blood counts in patients and reduce their need for transfusions; compare survival of patients who respond to ATG and cyclosporine treatment with those who do not respond; and determine the side effects of the treatment. Myelodysplasia is thought to result from an immune system abnormality in which cells called lymphocytes attack the marrow's blood-forming cells. The resulting deficiencies of platelets and red and white blood cells cause anemia, susceptibility to infections, and easy bruising and bleeding. Various therapies, such as blood transfusions for anemia and bleeding, antibiotics for infection, chemotherapy and bone marrow transplantation are used to treat myelodysplasia, but all have disadvantages and some carry serious risks. Patients 18 years of age and older with myelodysplasia may be eligible for this study. Candidates will be screened with a physical examination and medical history, blood tests, chest X-ray, electrocardiogram and bone marrow biopsy (removal of a marrow sample from the hipbone for microscopic examination).
Study Details
Timeline
Interventions
Antithymocyte globulin (ATG) intravenous infusion: 40mg/kg/day. Infusion over 6 hours on day 1-4.
Cyclosporine (CsA) intravenous infusion: 5mg/kg. Infusion on day 14 administered twice a day.