S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
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.
|Leukemia Myelodysplastic Syndromes||Biological: anti-thymocyte globulin Drug: cyclosporine||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)|
- total response [ Time Frame: after induction therapy is completed ]
|Study Start Date:||August 2001|
|Study Completion Date:||January 2007|
|Primary Completion Date:||July 2003 (Final data collection date for primary outcome measure)|
Biological: anti-thymocyte globulin
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016419
Show 94 Study Locations
|Study Chair:||Charles A. Schiffer, MD||Barbara Ann Karmanos Cancer Institute|