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| Sponsor: | Sangstat Medical Corporation |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017550 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes |
Biological: anti-thymocyte globulin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | 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) |
| Study Start Date: | August 2001 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed early myelodysplastic syndrome (MDS) with less than 10% bone marrow blasts
Transfusion-dependent
History of prior transfusions and 2 consecutive (at least 21 days apart) hemoglobin levels less than 8.0 g/dL or platelet counts less than 20,000/mm^3 during the past 2 months
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, District of Columbia | |
| Washington Cancer Institute | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| University of Florida Health Science Center | |
| Gainesville, Florida, United States, 32610-0296 | |
| Veterans Affairs Medical Center - Tampa (Haley) | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Rush Cancer Institute | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Blood and Marrow Transplant | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Louisiana | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Missouri | |
| Saint Louis University Cancer Center | |
| Saint Louis, Missouri, United States, 63110-2539 | |
| Siteman Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| University of Missouri Kansas City School of Medicine | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-7680 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| James P. Wilmot Cancer Center | |
| Rochester, New York, United States, 14642 | |
| New York Presbyterian Hospital - Cornell Campus | |
| New York, New York, United States, 10021 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| Texas Oncology P.A. | |
| Dallas, Texas, United States, 75230-2503 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226-3596 | |
| Canada, Alberta | |
| Foothills Hospital | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, British Columbia | |
| Department of Medicine | |
| Vancouver, British Columbia, Canada, V5Z 4E3 | |
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Chair: | Elizabeth C. Squiers, MD | Sangstat Medical Corporation |
More Information
| Study ID Numbers: | CDR0000068709, SMC-101-1020, RUSH-MDS-2000-04 |
| Study First Received: | June 6, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00017550 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory anemia refractory anemia with excess blasts de novo myelodysplastic syndromes previously treated myelodysplastic syndromes |
|
Disease Precancerous Conditions Immunologic Factors Hematologic Diseases Myelodysplastic Syndromes Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Antilymphocyte Serum Preleukemia Neoplasms Pathologic Processes Syndrome Bone Marrow Diseases |