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A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome Clinical research trials and A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome. A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome clinical trial. Human subjects often get the best healthcare available for their A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome  A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome
A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome
For Condition: Hematologic Diseases,Myelodysplastic Syndromes
Status: Completed
Sponsor(s): Warren G Magnuson Clinical Center (CC) ,
Synopsis: 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 cell activity. Immunosuppressive therapy may therefore reverse the cytopenia. In a phase II pilot study of anti-thymocyte globin (ATG) to treat myelodysplastic syndrome (MDS); 41% of patients (61% of patients with refractory anemia) have responded in terms of transfusion independence. Recently, Jonasova et al [32] reported a 82% substantial hematological response rate in 18 patients with MDS of the refractory anemia (RA) subtype treated with cyclosporine alone. Just over 50% of the patients in this series had MDS of the hypocellular type. Cyclosporine alone if indeed efficacious would be a powerful therapeutic option that could be readily used by hematologists in the community to treat patients with MDS. This efficacy needs to be proven in a larger study which includes patients with the other subtypes of MDS and more patients with the non-hypocellular forms of MDS (which constitute approximately 70% of the cases in the community). As MDS is a heterogeneous group of disorders, a randomized comparison with the other immunomodulating intervention of proven benefit, ATG, is appropriate. In this randomized study patients with MDS will receive either ATG alone or cyclosporine alone.
Details: 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 cell activity. Immunosuppressive therapy may therefore reverse the cytopenia. In a phase II pilot study of anti-thymocyte globulin (ATG) to treat myelodysplastic syndrome (MDS); 41% of patients (61% of patients with refractory anemia) have responded in terms of transfusion independence. Recently, Jonasova et al [32] reported a 82% substantial hematological response rate in 18 patients with MDS of the refractory anemia (RA) subtype treated with cyclosporine alone. Just over 50% of the patients in this series had MDS of the hypocellular type. Cyclosporine alone if indeed efficacious would be a powerful therapeutic option that could be readily used by hematologists in the community to treat patients with MDS. This efficacy needs to be proven in a larger study which includes patients with the other subtypes of MDS and more patients with the non-hypocellular forms of MDS (which constitute approximately 70% of the cases in the community). As MDS is a heterogeneous group of disorders, a randomized comparison with the other immunomodulating intervention of proven benefit, ATG, is appropriate. In this randomized study patients with MDS will receive either ATG alone or cyclosporine alone.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: MDS of RA & RAEB sub-types. No current treatment and off other treatments for at least two weeks. ECOG performance status less than or equal to 2. No MDS of FAB sub-group' refractory anemia with ring sideroblasts' (RARS). No transforming to acute leukemia (FAB sub-group RAEB-Tie.; greater than 20% blasts in marrow aspirate). No hypoplastic marrow without one major or two minor criteria as outlined in table 3 of the appendix. No one being treatment with growth factors or cyclosporine within four weeks prior to entry to protocol. No previous treatment with ATG. No ECOG performance status of greater than 2. No active uncontrolled infection. No women which current pregnancy, or unwilling to take oral contraceptives if of childbearing potential. No patients for whom bone marrow transplant is indicated as primary therapy. No one age less than 18 years. Must be able to give informed consent. No HIV positive patients. No active malignant disease (excluding basal cell carcinoma). No one with serum creatine greater than 2mg/dl. No patients who are moribund or patients with concurrent hepatic, renal, cardiac, metabolic, or any disease of such severity that death within 7-10 days is likely.
Total Enrollment: 182
Location and Contact Information:
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990021; 99-CC-0021
Study Start Date: December 4, 1998
Record last reviewed: December 3, 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001839
Other Myelodysplastic Syndromes Studies:
1. Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
2. Bevacizumab in Treating Patients With Myelodysplastic Syndrome
3. Umbilical Cord Blood Transplantation in Treating Patients With Severe Aplastic Anemia, Malignant Thymoma, or Myelodysplasia
4. Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
5. A Survival Study in Patients with High Risk Myelodysplastic Syndromes Comparing Azacitidine versus Conventional Care
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A Randomized Trial of Antithymocyte Globulin versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome
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