Status:
COMPLETED
Thalidomide at Low Dose for the Treatment of Patient With Myelodysplastic Syndromes - THAL-SMD-200
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 wee...
Detailed Description
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00455910
Start Date
January 1 2003
End Date
March 1 2007
Last Update
April 4 2007
Active Locations (20)
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1
CHU d'Angers
Angers, France, 49 033
2
CH d'Avignon
Avignon, France, 84 000
3
CH de la Cote Basque
Bayonne, France, 64 100
4
Hopital Avicenne
Bobigny, France, 93009