An Open Label, Prospective, Stratified, Randomized, Controlled, Multi-Center, Phase IIB Study of the Impact of Thymoglobulin Therapy on Transfusion Needs of Patients With Early Myelodysplastic Syndrome (MDS)
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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Elizabeth C. Squiers, MD
Study Chair
Sangstat Medical Corporation
United States: Federal Government
CDR0000068709
NCT00017550
August 2001
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
New York Medical College | Valhalla, New York 10595 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
James P. Wilmot Cancer Center | Rochester, New York 14642 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Rush Cancer Institute | Chicago, Illinois 60612 |
Washington Cancer Institute | Washington, District of Columbia 20010 |
Saint Louis University Cancer Center | Saint Louis, Missouri 63110 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Texas Oncology P.A. | Dallas, Texas 75230-2503 |
Indiana Blood and Marrow Transplant | Beech Grove, Indiana 46107 |
University of Missouri Kansas City School of Medicine | Kansas City, Missouri 64111 |