Etude : 63935937MDS3001 / IMerge



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : 63935937MDS3001

Nom : IMerge

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 07/07/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

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 : STUDY DESIGN:
This is a Phase 2/3, multicenter study of imetelstat that consists of 2 parts.
- Part 1 is an open-label, single-arm design to assess the efficacy and safety of imetelstat. Approximately 55 participants will be enrolled in Part 1, including the expansion cohort, and be followed-up for safety, hematologic improvement and reduction in transfusion requirement.
- Part 2 of the study will be initiated if data from Part 1 are supportive of a satisfactory benefit/risk profile. Part 2 is a double-blind, randomized design to compare the efficacy of imetelstat with placebo. Approximately 170 eligible participants will be randomized in a 2:1 ratio to receive either imetelstat or placebo, respectively.
Each part of the study will consist of 3 phases: a Screening phase (up to 28 days); a treatment phase; and a post-treatment follow-up phase which will continue until death, lost to follow-up, withdrawal of consent, or the End of the Study (whichever occurs first). The End of the Study is defined as 2 years after the study entry of the last participant or anytime the sponsor terminates the study, whichever comes first.

STUDY ARMS:
- Experimental: Part 1: Imetelstat
Imetelstat will be administered at a starting dose of 7.5 milligram per kilogram (mg/kg) given intravenously every 4 weeks, until disease progression, unacceptable toxicity, or withdrawal of consent, or lack of response.
- Experimental: Part 2: Imetelstat
Imetelstat will be administered at a starting dose of 7.5 milligram per kilogram (mg/kg) given intravenously every 4 weeks, until disease progression, unacceptable toxicity, or withdrawal of consent, or lack of response.
- Placebo Comparator: Part 2: Placebo
Matching Placebo to Imetelstat will be administered.

MAIN OBJECTIVE:
- Part 1: To evaluate the efficacy and safety of imetelstat in transfusion dependent subjects with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment.
- Part 2: To compare the efficacy, in terms of RBC TI, of imetelstat to placebo in transfusion dependent subjects with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment.

SECONDARY OBJECTIVES:
- To assess the safety of imetelstat in subjects with MDS
- To assess the time to RBC TI and duration of RBC TI
- To assess the rate of hematologic improvement
- To assess the rates of CR or PR
- To assess OS
- To assess time to progression to AML
- To assess the rate and amount of supportive care, including transfusions and myeloid growth factors
- To evaluate the pharmacokinetics and immunogenicity of imetelstat in subjects with MDS
- To assess the effect of imetelstat treatment on patient reported outcomes (PROs)
- To assess the effect of treatment on medical resource utilization

Phase : II/III

Stade : NA

1, Rechute, Réfractaire
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 : - Man or woman greater than or equal to (>=) 18 years of age
- Diagnosis of myelodysplastic syndrome (MDS) according to WHO criteria or French-American-British (FAB) classification confirmed by bone marrow aspirate and biopsy within 12 weeks prior to Study Entry. A local laboratory report from this diagnostic bone marrow aspirate and biopsy must be reviewed and approved by the sponsor
- International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS
- Red blood cell (RBC) transfusion dependent, defined as requiring 4 units RBC over 8 weeks during the 12 weeks prior to Study Entry; pre-transfusion hemoglobin (Hb) should be less than equal to 9.0 gram per deciliter (g/dL) to count towards the 4 units total
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Critères de non-inclusion : - Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients
- Participant has received an investigational drug or used an invasive investigational medicaldevice within 30 days prior to Study Entry or is currently enrolled in an investigational study
- Prior treatment with imetelstat
- Have received any chemotherapy, immunomodulatory or immunosuppressive therapy, corticosteroids greater than 30 milligram per day prednisone or equivalent, or growth factor treatment within 28 days prior to study entry
- Have received other treatments for MDS within 4 weeks prior to Study Entry
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02598661
Promoteur :
Geron Corporation
Type de sponsor : Industriel
Geron Corporation
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Bruno QUESNEL

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Statut de l'essai : OUVERT

MAJ : 30/06/2020