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Antithymocyte Globulin and Cyclosporine 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: NCT00004208
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:
The main objective of this trial is to evaluate the efficacy and toxicity of intensive immuno-suppression with ATG + CSA versus best supportive care in patients with transfusion dependent low and intermediate risk myelodysplastic syndrome (MDS).

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: ATG + CSA Behavioral: Supportive care Phase 3

Detailed Description:

This trial will answer the question whether immuno-suppression improves hematopoesis and reduces transfusion requirements analogous to patients with aplastic anemia as the short-term outcome, and whether immuno-suppression accelerates leukemic transformation and influences survival as the long-term outcome.

Primary endpoint: best response (CR + PR) rate at month 6

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2000
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Active Comparator: Arm A: ATG + CSA

Treatment consists of 15 mg/kg ATG (Mérieux; horse antithymocyte globulin; i.e. 1.5 vial/10 kg of body weight/day) given over 8-12 hours for 5 consecutive days.

Cyclosporine A (CSA) will be administered orally in a dose of 2.5 mg/kg bid starting day 1 and continued through day 180.

Drug: ATG + CSA
Mérieux; horse antithymocyte globulin (ATG) + Cyclosporine A (CSA)

Arm B: Supportive care
Patients randomized to this arm will be treated as outpatients.
Behavioral: Supportive care
Patients randomized to this arm will be treated as outpatients.

Primary Outcome Measures :
  1. Best response rate (CR + PR) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Response rate at month 3, time to response, quality and duration of response, and proportions of relapse/progression in responders [ Time Frame: 2 and 5 years after first response ]
  2. Overall survival [ Time Frame: 2 and 5 years ]
  3. Leukemia-free survival [ Time Frame: 2 and 5 years ]
  4. Transformation-free survival [ Time Frame: 2 and 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Hypoplastic MDS, or MDS subtype RA, RAS or RAEB with ≤ 10% blasts, or RAEB with 10-20% blasts and the patient refusing or not eligible for the MDS high risk protocol (EORTC 06961)

  • Transfusion dependence < 24 months or neutrophils < 0.5 × 109/l.
  • ECOG/SAKK performance status ≤ 2
  • Age > 18 years
  • No active uncontrolled infection
  • No prior chemotherapy or radiotherapy
  • No history of heart failure, clinically relevant cardiac arrhythmia or other hemato-oncological disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004208

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Basel, Switzerland, CH-4031
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Jakob R. Passweg, MS Kantonsspital Basel
Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00004208    
Other Study ID Numbers: SAKK 33/99
SWS-SAKK-33/99 ( Other Identifier: SAKK )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Swiss Group for Clinical Cancer Research:
refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions