Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
- Conditions
- Myelodysplastic Syndromes
- Registration Number
- NCT00017550
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be effective treatment for myelodysplastic syndrome. It is not yet known whether immunosuppressive therapy is more effective than supportive care in treating myelodysplastic syndrome.
PURPOSE: Randomized phase II trial to compare the effectiveness of antithymocyte globulin with that of supportive care in treating patients who have myelodysplastic syndrome.
- Detailed Description
OBJECTIVES:
* Compare the clinical response rate of patients with early myelodysplastic syndrome treated with rabbit anti-thymocyte globulin vs standard supportive care.
* Evaluate the safety of anti-thymocyte globulin in these patients.
* Compare the time to and duration of clinical response, rates of partial response and therapy failure, and rate of disease progression in patients treated with these regimens.
* Compare the ECOG performance score, number of transfusions and/or growth factor use, and maximum time between transfusions in patients treated with these regimens.
* Compare the infection risk, use of medical resources, and quality of clinical response in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to myelodysplastic syndrome (MDS) subtype (refractory anemia (RA) vs RA with excess blasts or hypocellular MDS). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive rabbit anti-thymocyte globulin (ATG) IV over at least 8-12 hours on days 1-4.
* Arm II: Patients receive standard supportive therapy for 6 months. At the end of 6 months, patients may receive ATG as in arm I.
Patients are followed for 6 months.
PROJECTED ACCRUAL: A total of 72 patients (48 in arm I and 24 in arm II) will be accrued within a minimum of 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Department of Medicine
🇨🇦Vancouver, British Columbia, Canada
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Indiana Blood and Marrow Transplant
🇺🇸Beech Grove, Indiana, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Rush Cancer Institute
🇺🇸Chicago, Illinois, United States
University of Missouri Kansas City School of Medicine
🇺🇸Kansas City, Missouri, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
Foothills Hospital
🇨🇦Calgary, Alberta, Canada
Texas Oncology P.A.
🇺🇸Dallas, Texas, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
New York Medical College
🇺🇸Valhalla, New York, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States