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RATIONALE: Antithymocyte globulin and cyclosporine may improve blood counts in patients with myelodysplastic syndrome. It is not yet known whether antithymocyte globulin and cyclosporine are more effective than standard therapy for myelodysplastic syndrome.
PURPOSE: This randomized phase III trial is studying antithymocyte globulin and cyclosporine to see how well they work compared to standard therapy in treating patients with myelodysplastic syndrome.
- Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine versus best supportive care in patients with transfusion dependent low or intermediate risk myelodysplastic syndrome.
- Determine whether immunosuppression improves hematopoiesis and reduces transfusion requirements of these patients.
- Determine whether immunosuppression accelerates leukemic transformation and influences survival of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and risk group.
Patients are randomized to 1 of 2 treatment arms:
- Arm I: Patients receive antithymocyte globulin IV over 3 hours on days 1-5 and oral cyclosporine twice daily on days 1-180.
- Arm II: Patients receive standard supportive care without antithymocyte globulin and cyclosporine.
Patients are followed at 1, 3, and 6 months, then every 6 months for 1.5 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 84 patients (42 per arm) will be accrued for this study.
Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment
anti-thymocyte globulin, cyclosporine
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:20-0400
This study was designed to test the safety and efficacy of up to 3 pancreatic alloislet transplants in type 1 diabetic patients with hypoglycemia unawareness. 6 subjects were transplanted...
RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be an effective treatment for myelodysplastic syndrome. PURPOSE: Phase II trial to study the effectivene...
RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be effective treatment for myelodysplastic syndrome. It is not yet known whether immunosuppressive therap...
Approximately 40% of the patients with myelodysplastic syndrome (MDS) die as a consequence of their cytopenia. As in aplastic anemia, the cytopenia of MDS may be partly due to cytotoxic T...
The different mechanisms of action between Antithymocyte globulin and cyclosporine can improve the effectivity when both are used in combination in patients with myelodysplastic syndrome.
Myelodysplastic syndromes are characterised by ineffective erythropoiesis leading to anaemia. Sotatercept (ACE-011) is a novel activin receptor type IIA fusion protein that acts as a ligand trap to ne...
Genomic sequencing technologies have identified isocitrate dehydrogenase (IDH) mutations in haematological malignancies. The prognostic implications of somatic IDH mutation (mIDH) in myelodysplastic s...
Although commonly associated with high-grade myelodysplastic syndrome (MDS) and MDS with a complex karyotype, TP53 mutations also occur in low-grade MDS and MDS with a non-complex karyotype. In latter...
The effects of erythropoietin on osteoblasts and bone formation are controversially discussed. Since patients with myelodysplastic syndromes often display excessively high erythropoietin level, we aim...
Myelodysplastic syndromes are characterized by genetic and clinical heterogeneity. Some mutations are able to drive clonal hematopoiesis without causing clinical consequences, while other mutations ma...
Clonal myeloid disorders that possess both dysplastic and proliferative features but are not properly classified as either MYELODYSPLASTIC SYNDROMES or MYELOPROLIFERATIVE DISORDERS.
These growth factors comprise a family of hematopoietic regulators with biological specificities defined by their ability to support proliferation and differentiation of blood cells of different lineages. ERYTHROPOIETIN and the COLONY-STIMULATING FACTORS belong to this family. Some of these factors have been studied and used in the treatment of chemotherapy-induced neutropenia, myelodysplastic syndromes, and bone marrow failure syndromes.
Clonal hematopoietic stem cell disorders characterized by dysplasia in one or more hematopoietic cell lineages. They predominantly affect patients over 60, are considered preleukemic conditions, and have high probability of transformation into ACUTE MYELOID LEUKEMIA.
Neoplasms located in the blood and blood-forming tissue (the bone marrow and lymphatic tissue). The commonest forms are the various types of LEUKEMIA, of LYMPHOMA, and of the progressive, life-threatening forms of the MYELODYSPLASTIC SYNDROMES.
Immunizing agent containing IMMUNOGLOBULIN G anti-Rho(D) used for preventing Rh immunization in Rh-negative individuals exposed to Rh-positive red blood cells.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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