Informations générales (source: ClinicalTrials.gov)
Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic Syndrome(MDS) Associated With a Deletion (DEL) 5q [31]
Interventional
Phase 2
Groupe Francophone des Myelodysplasies (Voir sur ClinicalTrials)
octobre 2006
octobre 2008
29 juin 2024
We are evaluating the incidence of significant hematological response, according to IWG
criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response
of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring
System [IPSS]) MDS with a deletion (del) 5q[31]
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Francois DREYFUS, Professor | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Henry Becquerel - 76 038 - Rouen - France | Aspasia Stamatoullas, MD | Contact (sur clinicalTrials) | |||
| CHU Brabois - 54511 - Vandoeuvre - France | Agnes GUERCI-BRESLER, MD | Contact (sur clinicalTrials) | |||
| Chu Purpan - 31059 - Toulouse - France | Odile BEYNE-RAUZY, Doctor | Contact (sur clinicalTrials) | |||
| Hoiptal St Louis - 75475 - Paris - France | Herve DOMBRET, Profesor | Contact (sur clinicalTrials) | |||
| Hopital Archet - 06202 - Nice - France | Laurence LEGROS | Contact (sur clinicalTrials) | |||
| Hopital Hotel Dieu - 44093 - Nantes - France | Jean-Luc HAROUSSEAU | Contact (sur clinicalTrials) | |||
| Hopital Jean-Bernard - 86021 - Poitiers - France | Francois GUILHOT, Professor | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU Hurriez - 59057 - Lille - France | Bruno QUESNEL, Profesor | Contact (sur clinicalTrials) | |||
| CHU Angers - 49033 - Angers - France | Mathilde HUNAULT-BERGER, MD | Contact (sur clinicalTrials) | |||
| Hopital Paoli Calmette - 13273 - Marseille - France | Norbert VEY, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age > 18 years at the time of signing the informed consent form
- MDS with IPSS scores Int-2 or high with deletion 5q(31)
- Prior thalidomide allowed
- Documented diagnosis of MDS (RA, RARS, RAEB, RAEB-T and CMML with WBC < 13,000/mm3
according to FAB classification) that meets IPSS criteria for intermediate-2 or
high-risk disease and has an associated del 5q[31] (the deleted chromosomal region
must include 5q[31]), with or without additional cytogenetic abnormalities
- Age > 18 years at the time of signing the informed consent form
- MDS with IPSS scores Int-2 or high with deletion 5q(31)
- Prior thalidomide allowed
- Documented diagnosis of MDS (RA, RARS, RAEB, RAEB-T and CMML with WBC < 13,000/mm3
according to FAB classification) that meets IPSS criteria for intermediate-2 or
high-risk disease and has an associated del 5q[31] (the deleted chromosomal region
must include 5q[31]), with or without additional cytogenetic abnormalities
- Pregnant or lactating females
- Prior therapy with lenalidomide
- MDS with IPSS scores low or Int-1
- Clinical neuropathy of greater than grade 2
- Proliferative (WBC ≥ 13,000/mL) chronic myelomonocytic leukemia (CMML)
- Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
- Use of androgens other than for treating hypogonadism