S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
- Conditions
- LeukemiaMyelodysplastic Syndromes
- Registration Number
- NCT00016419
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method total response after induction therapy is completed
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (94)
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Veterans Affairs Medical Center - West Los Angeles
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Genesis Medical Center
🇺🇸Davenport, Iowa, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Dwight David Eisenhower Army Medical Center
🇺🇸Fort Gordon, Georgia, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
Providence Hospital - Southfield
🇺🇸Southfield, Michigan, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Veterans Affairs Medical Center - Houston
🇺🇸Houston, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
MBCCOP - Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Biloxi
🇺🇸Biloxi, Mississippi, United States
Veterans Affairs Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
🇺🇸Phoenix, Arizona, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Cancer Institute
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Albany
🇺🇸Albany, New York, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States