Viewing Study NCT00016419



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Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00016419
Status: COMPLETED
Last Update Posted: 2015-03-06
First Post: 2001-05-06

Brief Title: S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
Sponsor: SWOG Cancer Research Network
Organization: SWOG Cancer Research Network

Study Overview

Official Title: A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome MDS
Status: COMPLETED
Status Verified Date: 2015-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
U10CA032102 NIH SWOG httpsreporternihgovquickSearchU10CA032102
S0020 OTHER None None