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Antithymocyte Globulin and Cyclosporine Compared With Standard Therapy in Treating Patients With Myelodysplastic Syndrome

2014-08-27 03:58:20 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

- 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.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment

Conditions

Myelodysplastic Syndromes

Intervention

anti-thymocyte globulin, cyclosporine

Location

Universitaetsspital-Basel
Basel
Switzerland
CH-4031

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:20-0400

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