Myelodysplastic Syndrome Clinical Trial

Antithymocyte Globulin Compared With Supportive Care in Treating Patients With Myelodysplastic Syndrome

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.

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Full 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.

View Eligibility Criteria

Eligibility 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^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 is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Study ID:

NCT00017550

Recruitment Status:

Completed

Sponsor:

Genzyme, a Sanofi Company

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There are 26 Locations for this study

See Locations Near You

Washington Cancer Institute
Washington District of Columbia, 20010, United States
University of Florida Health Science Center
Gainesville Florida, 32610, United States
Sylvester Cancer Center, University of Miami
Miami Florida, 33136, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa Florida, 33612, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Rush Cancer Institute
Chicago Illinois, 60612, United States
Indiana Blood and Marrow Transplant
Beech Grove Indiana, 46107, United States
Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Tulane University School of Medicine
New Orleans Louisiana, 70112, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
University of Missouri Kansas City School of Medicine
Kansas City Missouri, 64111, United States
Saint Louis University Cancer Center
Saint Louis Missouri, 63110, United States
Siteman Cancer Center
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
New York Presbyterian Hospital - Cornell Campus
New York New York, 10021, United States
Mount Sinai Medical Center, NY
New York New York, 10029, United States
James P. Wilmot Cancer Center
Rochester New York, 14642, United States
New York Medical College
Valhalla New York, 10595, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Texas Oncology P.A.
Dallas Texas, 75230, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Foothills Hospital
Calgary Alberta, T2N 2, Canada
Department of Medicine
Vancouver British Columbia, V5Z 4, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 2

Study ID:

NCT00017550

Recruitment Status:

Completed

Sponsor:


Genzyme, a Sanofi Company

How clear is this clinincal trial information?

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