A Phase 2 interventional study of Thalidomide in Myelodysplastic Syndromes, sponsored by Groupe Francophone des Myelodysplasies. Completed at 20 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-04-04.
Sponsored by Groupe Francophone des Myelodysplasies · Phase 2, Interventional, and Treatment
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.
Thalidomide:
First part of the trial: 82 patients at 200mg/day given at bedtime x 12 weeks, decreased to 100mg/day if grade 1 or 2 side. Stopped temporally for 1 week if grade 3 or 4 side effects. Then reintroduced at the same dose. If side effects again, definitively stopped.
Responses evaluated at 12 weeks according to IWG criteria for the erythroid lineage
At week 12:
Second part of the trial: 30 patients treated at 50mg/day x 12 weeks. Responses evaluated at 12 weeks according to IWG criteria for the erythroid lineage
At week 12:
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's enrollment of 112 is above the median of 36 across 1,060 interventional studies indexed under Preleukemia.
Browse Preleukemia studies →Groupe Francophone des Myelodysplasies is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Efficacy evaluated at week 12 according to the IWG criterias
Safety
This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.
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Groupe Francophone des Myelodysplasies