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Home > "A" Clinical Trials Conditions > Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome  Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
For Condition: de novo myelodysplastic syndromes,previously treated myelodysplastic syndromes,Refractory Anemia,refractory anemia with excess blasts
Status: No longer recruiting
Sponsor(s): Sangstat Medical Corporation ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed early myelodysplastic syndrome (MDS) with less than 10% bone marrow blasts - Refractory anemia (RA) - RA with excess blasts (RAEB) - Hypocellular myelodysplasia - Low or intermediate-1 prognostic risk - Transfusion-dependent - Need for 2 or more units of red blood cells or platelets per month for 2 or more months prior to study OR - 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 - during the past 2 months - Hemoglobin no greater than 12.0 g/dL after prior transfusion - No myelosclerosis occupying more than 30% of bone marrow space - No RA with ringed sideroblasts, RAEB in transformation, or chronic myelomonocytic leukemia - No therapy-related MDS - No history of immune-related hematologic disorder (e.g., idiopathic thrombocytopenic purpura) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - See Disease Characteristics - No other causes of cytopenia unrelated to MDS (e.g., gastrointestinal blood loss) - Iron present on marrow examination OR - Transferrin saturation at least 20% and ferritin at least 50 ng/mL Hepatic: - Bilirubin no greater than 2 mg/dL OR - SGOT/SGPT no greater than 2 times normal - No active or chronic hepatitis B or C Renal: - Creatinine no greater than 2 mg/dL Cardiovascular: - No symptomatic cardiac disease - No congestive heart failure (even if medically controlled) - No myocardial infarction within the past 6 months Pulmonary: - No severe pulmonary disease - If history of pulmonary insufficiency, must have pO_2 at least 90 mm/Hg on room air or pCO_2 no greater than 40 mm/Hg Other: - No history of unresolved B12 or folate deficiency since diagnosis of MDS - No untreated acute or chronic infection (afebrile for 7 days without antibiotics prior to study) - No active or chronic HIV - No concurrent cytomegalovirus infection - No other malignancy within the past 2 years except adequately treated localized squamous cell or basal cell skin cancer or carcinoma in situ of the cervix - No concurrent drug or alcohol abuse - No significant medical or psychosocial problems - No known allergy to rabbit protein - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 8 weeks since prior biologic agents, colony-stimulating factors, or epoetin alfa for MDS - At least 8 weeks since other prior investigational biologic agents - No prior or concurrent bone marrow transplantation - No concurrent epoetin alfa - No concurrent growth factors except filgrastim (G-CSF) or sargramostim (GM-CSF) for neutropenic fevers - No other concurrent biologic agents Chemotherapy: - At least 8 weeks since prior cytotoxic drugs for MDS - Concurrent chemotherapy for clinical indications of disease progression or leukemic transformation allowed Endocrine therapy: - At least 8 weeks since prior androgenic hormonal therapy for MDS - At least 8 weeks since prior danazol for MDS Radiotherapy: - No prior radiotherapy Surgery: - No prior organ transplantation Other: - At least 8 weeks since prior investigational drugs - At least 8 weeks since prior immunosuppressive drugs or other drugs for MDS - No concurrent immunosuppressive therapy - No other concurrent experimental drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ElizabethSquiers, Study Chair, Sangstat Medical Corporation
James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
Saint Louis University Cancer Center
St. Louis, Missouri, 63110-2539
United States
University of Missouri Kansas City School of Medicine
Kansas City, Missouri, 64111
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Indiana Blood and Marrow Transplant
Beech Grove, Indiana, 46107
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Foothills Hospital
Calgary, Alberta, T2N 2T9
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Siteman Cancer Center
St. Louis, Missouri, 63110
United States
Rush Cancer Institute
Chicago, Illinois, 60612
United States
Department of Medicine
Vancouver, British Columbia, V5Z 4E3
Canada
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Texas Oncology P.A.
Dallas, Texas, 75230-2503
United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
New York Medical College
Valhalla, New York, 10595
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3596
United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0296
United States
Additional Information:
Study ID Numbers: CDR0000068709; RUSH-MDS-2000-04,SMC-101-1020
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017550
Other De Novo Myelodysplastic Syndromes Studies:
1. Gemtuzumab in Treating Patients With Myelodysplastic Syndrome
2. PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome
3. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
4. Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
5. Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other de novo myelodysplastic syndromes Clinical Trials
Other New Jersey Clinical Trials
Other Hackensack Clinical Trials
Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome
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