Informations générales (source: ClinicalTrials.gov)
A Phase II Study of Darbepoetin Alpha in Myelodysplastic Syndromes (MSD)
Interventional
Phase 2
Groupe Francophone des Myelodysplasies (Voir sur ClinicalTrials)
décembre 2006
juillet 2008
29 juin 2024
This is an evaluation of the effectiveness of darbepoetin alpha in treating anemia of MDS
patients with an International Prognostic Scoring System (IPSS) score of low or
intermediate 1.
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) | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Michel TULLIEZ, Profesor | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Hôtel-Dieu | Nicole CASADEVALL, Profesor | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Francoise ISNARD, MD | Contact (sur clinicalTrials) | |||
| HIA PERCY | Thierry DE REVEL, Profesor | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH de la Cote Basque - 64 100 - Bayonne - France | Frederic Bauduer, MD | Contact (sur clinicalTrials) | |||
| CHRU Limoges - 87046 - Limoges - France | Dominique BOURDESSOULE | Contact (sur clinicalTrials) | |||
| CHU Albert Michallon - 38043 - Grenoble - France | Jean-Yves CAHN, Professor | Contact (sur clinicalTrials) | |||
| CHU Archet - 06202 - Nice - France | Laurence LEGROS, DOCTOR | Contact (sur clinicalTrials) | |||
| CHU d'Angers - 43033 - Angers - France | Mathilde HUNAULT-BERGER, Doctors | Contact (sur clinicalTrials) | |||
| CHU d'Avignon - 84000 - Avignon - France | Bohrane SLAMA, Doctor | Contact (sur clinicalTrials) | |||
| CHU de Brest - Hopital Morvan - 29 609 - Brest - France | Christian Berthou, MD | Contact (sur clinicalTrials) | |||
| CHU de Caen - 14033 - Caen - France | Stéphane CHEZE, MD | Contact (sur clinicalTrials) | |||
| CHU Robert Debre - 51092 - Reims - France | Chantal HIMBERLIN, Doctor | Contact (sur clinicalTrials) | |||
| Hopital Bretonneau - 37044 - Tours - France | Philippe COLOMBAT, Profesor | Contact (sur clinicalTrials) | |||
| Hopital Hautepierre - 67098 - Strasbourg - France | Shanti AME, MD | Contact (sur clinicalTrials) | |||
| Hopital Henri Becquerel - 76038 - Rouen - France | Aspasia STAMATOULLAS, Doctor | 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) | |||
| Hopital Purpan - 31031 - Toulouse - France | Guy LAURENT, Professor | Contact (sur clinicalTrials) | |||
| Hopital St Louis - 75475 - Paris - France | Herve DOMBRET, Profesor | 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 d'Amiens - 800054 - Amiens - France | Ghandi DAMAJ, MD | Contact (sur clinicalTrials) | |||
| CHU de Dijon - 21034 - Dijon - France | Denis CAILLOT | Contact (sur clinicalTrials) | |||
| CHU Nancy-Brabois - 54511 - Vandoeuvre les Nancy - France | Agnes Guerci-Bresler, MD | Contact (sur clinicalTrials) | |||
| CHU Pontchaillou - 35033 - Rennes - France | Martine ESCOFFRE-BARBE | Contact (sur clinicalTrials) | |||
| Hopital Edouard Herriot - 69437 - Lyon - France | Youcef CHELGHOUM, MD | Contact (sur clinicalTrials) | |||
| Hopital Paoli Calmette - 13273 - Marseille - France | Norbert VEY, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- MDS of the following subtypes:
- RA, RAS, RAEB with marrow blasts < 10% (according to FAB),
- RA, RARS, RCMD, RAEB 1, CMML 1 with ≤ 10% WBC counts < 13000/mm3 (according to
WHO classification)
- Anemia, defined by Hb < 10 g/dl or RBC transfusion requirement in the absence of
other causes of anemia (especially renal failure, iron, or folate deficiency)
- IPSS ≤ 1(ie IPSS low or intermediate 1)
- EPO level < 500 UI/L
- Ability to perform physical tests of exercise tolerance
- No renal failure (creatinine ≤ 120% normal upper value for the center)
- No underlying severe condition
- ECOG performance status score of 0, 1, or 2
- Must be 18 years of age or older at the time of screening
- Written informed consent
- MDS of the following subtypes:
- RA, RAS, RAEB with marrow blasts < 10% (according to FAB),
- RA, RARS, RCMD, RAEB 1, CMML 1 with ≤ 10% WBC counts < 13000/mm3 (according to
WHO classification)
- Anemia, defined by Hb < 10 g/dl or RBC transfusion requirement in the absence of
other causes of anemia (especially renal failure, iron, or folate deficiency)
- IPSS ≤ 1(ie IPSS low or intermediate 1)
- EPO level < 500 UI/L
- Ability to perform physical tests of exercise tolerance
- No renal failure (creatinine ≤ 120% normal upper value for the center)
- No underlying severe condition
- ECOG performance status score of 0, 1, or 2
- Must be 18 years of age or older at the time of screening
- Written informed consent
- Therapy related MDS
- MDS with IPSS > 1 (int 2 or high score)
- Chronic myelomonocytic leukemia with > 10% marrow blasts or WBC > 13000/mm3
- Uncontrolled systemic hypertension
- Cardiac condition: uncontrolled angina, congestive heart failure, or uncontrolled
cardiac arrhythmia
- Creatinine level > 120% upper normal value for the center.
- Clinically significant systemic infection or chronic inflammatory disease (eg,
rheumatoid arthritis) present at the time of screening
- Serum folate ≤ 2.0 ng/mL or vitamin B12 ≤ 200 pg/mL (anemia related to nutritional
deficiencies)
- Other causes of anemia (eg, hemolysis, bleeding, sickle cell anemia, renal disease)
- Pregnant (ie, positive βhCG test) or breast feeding female subjects
- Women of childbearing potential and not using adequate contraceptives
- Known positive antibody response to an erythropoietic growth factor
- Known hypersensitivity to darbepoetin alpha or any of its excipients, or to
recombinant erythropoietins
- Patient unable to understand the protocol or to be adequately followed up.
- History of seizures
- Previous history of thrombotic events
- Concomitant treatment with thalidomide