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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00017550
Other study ID # CDR0000068709
Secondary ID SMC-101-1020RUSH
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2000
Est. completion date November 2003

Study information

Verified date March 2003
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 0
Est. completion date November 2003
Est. primary completion date November 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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^3 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
anti-thymocyte globulin


Locations

Country Name City State
Canada Foothills Hospital Calgary Alberta
Canada Princess Margaret Hospital Toronto Ontario
Canada Department of Medicine Vancouver British Columbia
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Indiana Blood and Marrow Transplant Beech Grove Indiana
United States Rush Cancer Institute Chicago Illinois
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Texas Oncology P.A. Dallas Texas
United States University of Florida Health Science Center Gainesville Florida
United States Hackensack University Medical Center Hackensack New Jersey
United States Holden Comprehensive Cancer Center Iowa City Iowa
United States University of Kansas Medical Center Kansas City Kansas
United States University of Missouri Kansas City School of Medicine Kansas City Missouri
United States Sylvester Cancer Center, University of Miami Miami Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Tulane University School of Medicine New Orleans Louisiana
United States Mount Sinai Medical Center, NY New York New York
United States New York Presbyterian Hospital - Cornell Campus New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States James P. Wilmot Cancer Center Rochester New York
United States Saint Louis University Cancer Center Saint Louis Missouri
United States Siteman Cancer Center Saint Louis Missouri
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States Veterans Affairs Medical Center - Tampa (Haley) Tampa Florida
United States New York Medical College Valhalla New York
United States Washington Cancer Institute Washington District of Columbia
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada, 

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