Etude : LODEFI /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : LODEFI

Nom :

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 18/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Phase II Trial Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk (MDS) Myelodysplastic Syndrome Resistant or Relapsing After ESA Agents (LODEFI)

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C96 - Tumeurs malignes des tissus lymphoïde, hématopoïétique et apparentés, autres et non précisées
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Single Group Assignment
Experimental: Deferasirox
Efficacy of 3.5mg/kg/day


Phase : II

Stade : Localement avancé à Métastasique

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : Patients with MDS according to WHO 2008 criteria (refractory anemia with multilineage dysplasia, RA (refractory anemia), refractory anemia with ringed sideroblasts (RARS) including CMML-1 (chronic myelomonocytic leukemia) type 1 with <10% blasts)
low risk (IPSS-R very low, low and intermediate)
in primary or secondary failure after erythropoiesis stimulating agents (ESAs), (either epoetins (≥60,000 units / week), or darbepoetin (≥250 μg / week), administered for at least 12 weeks, as defined by the IWG criteria 2006 (no erythroid response at 12 weeks, or more than 15g / l decrease in Hb after response to ESAs) PS: Patients with low transfusion of less than (<) 4RBP assessed over 4 months (RBP administered for patients with Hb ≤ 9g / dl) will be accepted)
age ≥ 18 years
ECOG ≤2
informed consent dated and signed
affiliated to a social security scheme
Women and men of childbearing potential must have effective contraception throughout the duration of the study and up to 4 days after the last administration of deferasirox

Critères de non-inclusion : Transfusion dependent patient (≥) 2 red blood cells (RBP) per 2-month period evaluated over 4 months between M-4 and M0
Patients with high-risk MDS (based on IPSS-R) and patients with other hematologic and non-haematological malignancies who should not benefit from chelation therapy due to rapid progression of their disease
Ferritin <200 ng / ml
Iron overload: ferritin> 1000 ng / ml
Creatinine clearance according to MDRD ≤60 ml / min
5q- deletion to karyotype
Patient eligible for allograft
Patient participating in another interventional clinical study or exclusion period from another study
History of cancer treated or untreated for less than 5 years, whether or not there are signs of relapse or metastases, with the exception of basocellular cancers.
Persons referred to in Articles L1121-5 to L1121-8 of the CSP: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, can not not be included in clinical trials.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03387475
Promoteur :
CHU de Grenoble
Type de sponsor : Institutionnel
Boulevard de la Chantourne - Boulevard de la Chantourne
38000 GRENOBLE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :
Aspasia STAMATOULLAS-BASTARD

TEC / ARC / IDE :
Béatrice PERRE
beatrice.perre@
chb.unicancer.fr
02.32.08.24.98

Statut de l'essai : OUVERT

MAJ : 18/10/2019