NCT00016419

S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome

A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin	3.5 mg/kg/d IV over 12 hrs day 1
DRUG	cyclosporine	3 mg/kg bid days 5-94 then taper to 0 at day 124 PO

Timeline

• Start date: 2001-08-01
• Primary completion: 2003-07-01
• Completion: 2007-01-01
• First posted: 2003-01-27
• Last updated: 2015-03-06

Locations

94 sites across 1 country: United States