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)
- 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
- 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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Elizabeth C. Squiers, MD
Sangstat Medical Corporation
United States: Federal Government
|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|