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| Sponsor: | Swiss Group for Clinical Cancer Research |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004208 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes |
Biological: anti-thymocyte globulin Drug: cyclosporine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Antithymocyte Globulin (ATG) and Cyclosporine (CSA) to Treat Patients With Myelodysplastic Syndrome (MDS) - A Randomized Trial Comparing ATG + CSA With Best Supportive Care |
| Estimated Enrollment: | 84 |
| Study Start Date: | August 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and risk group.
Patients are randomized to 1 of 2 treatment arms:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of low or intermediate risk myelodysplastic syndrome (MDS) of less than 2 years duration with any of the following:
Transfusion dependence, defined by any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
More Information
| Study ID Numbers: | CDR0000067455, SWS-SAKK-33/99 |
| Study First Received: | January 21, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004208 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts |
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
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Anti-Infective Agents Disease Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Precancerous Conditions Hematologic Diseases Physiological Effects of Drugs Myelodysplastic Syndromes Enzyme Inhibitors Cyclosporins Immunosuppressive Agents |
Pharmacologic Actions Antilymphocyte Serum Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Antifungal Agents Syndrome Antirheumatic Agents Bone Marrow Diseases Dermatologic Agents |