• Complete and partial response rate at month 6 [ Designated as safety issue: No ]
  

• Response rate at month 3 [ Designated as safety issue: No ]
  
• Quality and duration of response at 2 and 5 years after first response [ Designated as safety issue: No ]
  
• Proportion of relapse to progression in responders at 2 and 5 years after first response [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Leukemia-free survival [ Designated as safety issue: No ]
  
• Transformation-free survival [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine versus best supportive care in patients with transfusion dependent low or intermediate risk myelodysplastic syndrome.
• Determine whether immunosuppression improves hematopoiesis and reduces transfusion requirements of these patients.
• Determine whether immunosuppression accelerates leukemic transformation and influences survival of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and risk group.

Patients are randomized to 1 of 2 treatment arms:

• Arm I: Patients receive antithymocyte globulin IV over 3 hours on days 1-5 and oral cyclosporine twice daily on days 1-180.
• Arm II: Patients receive standard supportive care without antithymocyte globulin and cyclosporine.

Patients are followed at 1, 3, and 6 months, then every 6 months for 1.5 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 84 patients (42 per arm) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of low or intermediate risk myelodysplastic syndrome (MDS) of less than 2 years duration with any of the following:

  • Hypoplasia
  • Refractory anemia
  • Refractory anemia with sideroblasts
  • Refractory anemia with excess of blasts (RAEB) with no greater than 10% blast cells in bone marrow
  • RAEB with 10-20% blast count, and patient refuses intensive chemotherapy on high risk MDS protocol (EORTC 06961) and is not eligible for bone marrow transplantation

• Transfusion dependence, defined by any of the following:

  • Packed red blood cell transfusions greater than 2 units per month for a period of at least 2 months
  • Untransfused hemoglobin level no greater than 8 g/dL
  • Platelet transfusions greater than 1 unit per 2 weeks for a period of greater than 1 month
  • Untransfused platelet count no greater than 20,000/mm^3
• No chronic myelomonocytic leukemia
• No refractory anemia with excess blasts in transformation
• Not scheduled for a bone marrow transplantation

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG/SAKK 0-2

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin no greater than 2.5 times upper limit of normal (ULN)
• No active chronic hepatitis B or C

Renal:

• Creatinine no greater than 2.5 times ULN

Cardiovascular:

• No history of heart failure
• No clinically relevant cardiac arrhythmia

Other:

• No other prior malignancy except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix
• No history of allergy to horse proteins, anaphylactic reactions to animal proteins, or serum sickness
• Not pregnant
• Fertile patients must use effective contraception
• HIV negative
• No active uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified