S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00016419|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Biological: anti-thymocyte globulin Drug: cyclosporine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||July 2003|
|Actual Study Completion Date :||January 2007|
- 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
- total response [ Time Frame: after induction therapy is completed ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016419
|Study Chair:||Charles A. Schiffer, MD||Barbara Ann Karmanos Cancer Institute|