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