Spots Global Cancer Trial Database for S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome

Study Description

Brief Summary: RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be an effective treatment for myelodysplastic syndrome. PURPOSE: Phase II trial to study the effectiveness of antithymocyte globulin plus cyclosporine in treating patients who have myelodysplastic syndrome.

Detailed Description: OBJECTIVES: * Determine the response in patients with myelodysplastic syndromes treated with anti-thymocyte globulin and cyclosporine. * Determine the frequency and severity of toxic effects of this regimen in these patients. * Assess the correlation between response to treatment and the in vitro assessment of T-lymphocyte subsets in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to myelodysplastic syndrome subclassification (refractory anemia \[RA\] vs RA with ringed sideroblasts vs RA with excess blasts). Patients receive induction therapy comprising anti-thymocyte globulin IV over 6-12 hours on days 1-4 and oral cyclosporine twice daily on days 5-94 followed by a taper until day 124. Patients who relapse after a response of at least 60 days may receive reinduction therapy comprising oral cyclosporine twice daily on days 1-90 followed by a taper until day 120. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months, every 2 months for 2 years, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 130 patients (53 with refractory anemia \[RA\], 33 with RA with ringed sideroblasts, and 44 with RA with excess blasts) will be accrued for this study within 14-22 months.

Keywords

Eligibility

Minimum Age: 15 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

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