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

Inclusion 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