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Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

Information source: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplastic Syndromes

Intervention: ATG + CSA (Drug); Supportive care (Behavioral)

Phase: Phase 3

Status: Completed

Sponsored by: Swiss Group for Clinical Cancer Research

Official(s) and/or principal investigator(s):
Jakob R. Passweg, MS, Study Chair, Affiliation: Kantonsspital Basel


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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Best response rate (CR + PR)

Secondary outcome:

Response rate at month 3, time to response, quality and duration of response, and proportions of relapse/progression in responders

Overall survival

Leukemia-free survival

Transformation-free survival

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Universitaetsspital-Basel, Basel CH-4031, Switzerland
Additional Information

Starting date: August 2000
Last updated: March 10, 2015

Page last updated: August 20, 2015

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