Thalidomide at Low Dose for the Treatment of Patient With Myelodysplastic Syndromes - THAL-SMD-200
Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
Summary
The GFM previously conducted a dose-escalating phase II trial of thalidomide in MDS with a
minimum dose of 200mg/d and a maximum dose 800mg/d. Responses were evaluated according to IWG
criteria at week 16 and thalidomide continued up to week 56 in responders. 82% patients
received at least 8 weeks of treatment and were evaluable. 59% had hematological improvement,
mainly on the erythroid lineage (Increase of Hemoglobin). Most responses were observed at low
doses and between 4 and 8 weeks.
The objectives of this trial (Thal-SMD-20) are to evaluate the efficacy and tolerance of
lower doses thalidomide in low risk MDS patients with transfusion-dependant anemia.