Thalidomide at Low Dose for the Treatment of Patient With Myelodysplastic Syndromes - THAL-SMD-200
NCT ID: NCT00455910
Last Updated: 2007-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2003-01-31
2007-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Thalidomide
Eligibility Criteria
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Inclusion Criteria
* Transfusion dependant anemia above 2 packed red blood cells (PRBC)/month
* ECOG index = 0, 1, 2
* No peripheral neurological disease
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Groupe Francophone des Myelodysplasies
OTHER
Principal Investigators
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Didier Bouscary, MD, Ph-D
Role: PRINCIPAL_INVESTIGATOR
Groupe Francophone des Myelodysplasies
Locations
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CHU d'Angers
Angers, , France
CH d'Avignon
Avignon, , France
CH de la Cote Basque
Bayonne, , France
Hopital Avicenne
Bobigny, , France
CHU de Brest - Hopital Morvan
Brest, , France
CHU Dijon
Dijon, , France
CHU Albert Michallon
Grenoble, , France
CHRU de Lille - Hopital C. Huriez
Lille, , France
CHU de Limoges
Limoges, , France
Institut Paoli Calmette
Marseille, , France
CHU de Nantes
Nantes, , France
CHU de Nice - Hopital de l'Archet 1
Nice, , France
Hotel Dieu
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital Cochin
Paris, , France
Hopital Necker
Paris, , France
CH Joffre
Perpignan, , France
Centre Henry Becquerel
Rouen, , France
CHU Purpan
Toulouse, , France
CHU Nancy-Brabois
Vandœuvre-lès-Nancy, , France
Countries
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References
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Bouscary D, Legros L, Tulliez M, Dubois S, Mahe B, Beyne-Rauzy O, Quarre MC, Vassilief D, Varet B, Aouba A, Gardembas M, Giraudier S, Guerci A, Rousselot P, Gaillard F, Moreau A, Rousselet MC, Ifrah N, Fenaux P, Dreyfus F; Groupe Francais des Myelodysplasies (GFM). A non-randomised dose-escalating phase II study of thalidomide for the treatment of patients with low-risk myelodysplastic syndromes: the Thal-SMD-2000 trial of the Groupe Francais des Myelodysplasies. Br J Haematol. 2005 Dec;131(5):609-18. doi: 10.1111/j.1365-2141.2005.05817.x.
Related Links
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website of French Group of Myelodysplasia
Other Identifiers
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CCPPRB Cochin 2402-1-1928
Identifier Type: -
Identifier Source: secondary_id
020895
Identifier Type: -
Identifier Source: org_study_id