Thalidomide for the Treatment of Cytopenias of Patients With Low Risk Myelodysplastic Syndromes
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:
- If no Hematological improvement (HI): increased to 300mg/day for 8 weeks and then
eventually to 400mg/day for 8 weeks more, if no HI.
- If Hematological improvement (HI): continued at the same dose.
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:
- If no Hematological improvement (HI): increased to 100mg/day for 8 weeks and then
eventually to 200mg/day for 8 weeks more, if no HI.
- If Hematological improvement (HI): continued at the same dose.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy evaluated at week 12 according to the IWG criterias
Didier Bouscary, MD, Ph-D
Principal Investigator
Groupe Francophone des Myelodysplasies
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
020895
NCT00455910
January 2003
March 2007
Name | Location |
---|