Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Antithymocyte Globulin and Cyclosporine Compared With Standard Therapy in Treating Patients With Myelodysplastic Syndrome

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Over 18	Other	SWS-SAKK-33/99 NCT00004208

Objectives

1. 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.
2. Determine whether immunosuppression improves hematopoiesis and reduces transfusion requirements of these patients.
3. Determine whether immunosuppression accelerates leukemic transformation and influences survival of these patients.

Entry Criteria

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/mm³



• No chronic myelomonocytic leukemia



• No refractory anemia with excess blasts in transformation



• Not scheduled for a bone marrow transplantation

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified

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

Expected Enrollment

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

Outcomes

Complete and partial response rate at month 6

Response rate at month 3
Quality and duration of response at 2 and 5 years after first response
Proportion of relapse to progression in responders at 2 and 5 years after first response
Overall survival
Leukemia-free survival
Transformation-free survival

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.

Passweg JR, Giagounidis A, Simcock M, et al.: Immunosuppression for patients with low and intermediate risk myelodysplastic syndrome: a prospective randomized multicenter trial comparing antithymocyte globulin + cyclosporine with best supportive care: SAKK 33/99. [Abstract] Blood 110 (11): A-1461, 2007.

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

A. Tichelli, MD, Protocol chair		Ph: 41-61-265-4254

Registry Information
Official Title		Antithymocyte Globulin (ATG) and Cyclosporine (CSA) to Treat Patients with Myelodysplastic Syndrome (MDS) - A Randomized Trial Comparing ATG + CSA with Best Supportive Care
Trial Start Date		2000-08-01
Registered in ClinicalTrials.gov		NCT00004208
Date Submitted to PDQ		1998-07-29
Information Last Verified		2007-01-03

Back to Top