Trial Information
Antithymocyte Globulin (ATG) and Cyclosporine (CSA) to Treat Patients With Myelodysplastic Syndrome (MDS). A Randomized Trial Comparing ATG + CSA With Best Supportive Care
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
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Best response rate (CR + PR)
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Jakob R. Passweg, MS
Investigator Role:
Study Chair
Investigator Affiliation:
Kantonsspital Basel
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 33/99
NCT ID:
NCT00004208
Start Date:
August 2000
Completion Date:
October 2011
Related Keywords:
- Myelodysplastic Syndromes
- refractory anemia
- refractory anemia with ringed sideroblasts
- refractory anemia with excess blasts
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- Myelodysplastic Syndromes
- Preleukemia
