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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Francophone des Myelodysplasies
• Treatments: Thalidomide

Criteria

Inclusion Criteria:

• Patients ≥18 years, with IPSS Low or Int-1 MDS

• Transfusion dependant anemia above 2 packed red blood cells (PRBC)/month

• ECOG index = 0, 1, 2

• No peripheral neurological disease

Exclusion Criteria:

• MDS patients with IPSS Int-2 or High

• Patients with less than 2 packed red blood cells (PRBC)/month

• Patients with previous history of venous thrombosis

• Patient treated with EPO +/- G-CSF in the 2 months before inclusion in the protocol

• Patient having received intensive chemotherapy in the 3 months before inclusion in the protocol

• Patient having received Thalidomide in a previous protocol

• Patient presenting an iron, B12 vitamin or folic acid uncorrected deficiency

• Patient with peripheral neurological disease

• Patient not being able to subject itself to a regular clinical and biological follow-up

• Pregnant patient or patient in a period of lactation

• Patient refusing to take a contraceptive treatment through out all the study

• Patient receiving drugs able to interfere with the mechanism of action of Thalidomide

• Patient refusing to sign the informed consent.