S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00016419
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

May 6, 2001
January 27, 2003
March 6, 2015
August 2001
July 2003   (Final data collection date for primary outcome measure)
total response [ Time Frame: after induction therapy is completed ]
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Complete list of historical versions of study NCT00016419 on Archive Site
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S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)

RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be an effective treatment for myelodysplastic syndrome.

PURPOSE: Phase II trial to study the effectiveness of antithymocyte globulin plus cyclosporine in treating patients who have myelodysplastic syndrome.


  • Determine the response in patients with myelodysplastic syndromes treated with anti-thymocyte globulin and cyclosporine.
  • Determine the frequency and severity of toxic effects of this regimen in these patients.
  • Assess the correlation between response to treatment and the in vitro assessment of T-lymphocyte subsets in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to myelodysplastic syndrome subclassification (refractory anemia [RA] vs RA with ringed sideroblasts vs RA with excess blasts).

Patients receive induction therapy comprising anti-thymocyte globulin IV over 6-12 hours on days 1-4 and oral cyclosporine twice daily on days 5-94 followed by a taper until day 124. Patients who relapse after a response of at least 60 days may receive reinduction therapy comprising oral cyclosporine twice daily on days 1-90 followed by a taper until day 120. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 6 months, every 2 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 130 patients (53 with refractory anemia [RA], 33 with RA with ringed sideroblasts, and 44 with RA with excess blasts) will be accrued for this study within 14-22 months.

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Biological: anti-thymocyte globulin
    3.5 mg/kg/d IV over 12 hrs day 1
  • Drug: cyclosporine
    3 mg/kg bid days 5-94 then taper to 0 at day 124 PO
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 2007
July 2003   (Final data collection date for primary outcome measure)


  • Morphologically confirmed myelodysplastic syndromes (MDS)

    • Refractory anemia (RA)
    • RA with ringed sideroblasts
    • RA with excess blasts
  • Low, intermediate-1, or intermediate-2 risk by International Prognostic Scoring System criteria
  • MDS secondary to prior chemotherapy and/or radiotherapy for other malignant disorders allowed
  • Must have received prior transfusions of at least 4 units of red blood cells for anemia within the past 60 days
  • Must be concurrently registered on SWOG-S9910 and SWOG-9007
  • Ineligible for or refused participation in SWOG-S9920 (HLA-identical sibling peripheral blood stem cell transplantation)



  • 15 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
  • HIV negative
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • See Disease Characteristics
  • Prior cytokines (e.g., interferon or interleukin), colony-stimulating factors, or epoetin alfa allowed
  • No prior bone marrow or stem cell transplantation
  • No concurrent growth factors (including epoetin alfa) except filgrastim (G-CSF) or sargramostim (GM-CSF) for neutropenia


  • See Disease Characteristics
  • No prior remission induction chemotherapy for MDS
  • Prior hydroxyurea allowed

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • Not specified


  • Prior amifostine allowed
  • No calcium-channel blockers (diltiazem, nicardipine, or verapamil), antifungals (fluconazole, itraconazole, or ketoconazole), antibiotics (clarithromycin or erythromycin), or other drugs (bromocriptine or danazol) that would increase cyclosporine concentrations for 48 hours before, during, and for 48 hours after cyclosporine
  • No antibiotics (nafcillin or rifampin) or anticonvulsants (carbamazepine, phenobarbital, or phenytoin) that would decrease cyclosporine concentrations for 14 days before and during cyclosporine
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
S0020 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
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Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Charles A. Schiffer, MD Barbara Ann Karmanos Cancer Institute
Southwest Oncology Group
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP