Etude : M15-954 / VERONA



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : M15-954 / VERONA

Situation thérapeutique : Induction

Traitement : Chimiothérapie / Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 29/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Une étude randomisée, en double aveugle, de phase 3 évaluant l'innocuité et l'efficacité du vénétoclax en association avec l'azacitidine chez les patients nouvellement diagnostiqués avec un syndrome myélodysplasique à haut risque (SMD à haut risque)

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 : Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS.

Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide.

Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

STUDY ARMS:
- Experimental: Arm 1: Venetoclax + Azacitidine (AZA)
Participants will receive venetoclax once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.

- Active Comparator: Arm 2: Placebo + Azacitidine
Participants will receive placebo once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.

MAIN OBJECTIVE:
To assess the efficacy of venetoclax in combination with AZA compared to placebo with AZA in treatment-naive higher-risk MDS.
The hypotheses corresponding to the primary objective is that venetoclax will improve the complete remission (CR) rate and overall survival (OS) when added to standard of care AZA treatment in patients newly diagnosed with higher-risk MDS.

SECONDARY OBJECTIVES:
1.To evaluate the safety of venetoclax in combination with AZA compared to placebo with AZA in higher-risk MDS populations
2.To evaluate patient-reported outcomes (PROs) for subjects on venetoclax in combination with AZA compared to placebo with AZA.

Phase : III

Stade : NA

1 (hémato)
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 : - Adult male or female, at least 18 years old. Diagnosis of MDS according to the 2016 WHO classification with presence of < 20% bone marrow blasts per bone marrow biopsy/aspirate at screening. Subject meets the following disease activity criteria:
•Overall IPSS-R score > 3 (intermediate, high, or very high; Appendix E);
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
•HSCT eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1. No prior therapy for MDS with any hypomethylating agent (for example, azacitidine, decitabine), chemotherapy or allogeneic stem cell transplantation.

Critères de non-inclusion : No previous diagnosis of:
•Therapy-related MDS (t-MDS)
•MDS evolving from a pre-existing myeloproliferative neoplasm (MPN)
•MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN
•No prior therapy for MDS with any hypomethylating agent (for example, azacitidine, decitabine), chemotherapy or allogeneic stem cell transplantation.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04401748
Promoteur :
ABBVIE
Type de sponsor : Industriel
ABBVIE
00000 HORS FRANCE

Coordonnateur :
CENTRE ABBVIE
abbvieclinicaltrials@abbvie.com
844-663-3742
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 : À VENIR

MAJ : 29/11/2021