Informations générales (source: ClinicalTrials.gov)
A Randomized, Open-label, Phase 3 Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Subjects With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL). (GLOW)
Interventional
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
avril 2018
avril 2029
24 mai 2025
The purpose of this study is to assess progression-free survival (PFS) from treatment
with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil
(G-Clb) as assessed by an Independent Review Committee (IRC).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | David GHEZ | 26/02/2024 12:39:40 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU Bretonneau - 37044 - Tours Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| CHU de Clermont Ferrand - 63000 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU Montpellier - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU-Nancy - 54511 - Vandoeuvre les Nancy - France | Contact (sur clinicalTrials) | ||||
| Hopital Claude Huriez - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hopital Haut Leveque Service Maladie Du Sang - 33604 - Pessac - France | Contact (sur clinicalTrials) | ||||
| Institut Universitaire du Cancer Toulouse Oncopole - 31059 - Toulouse Cedex 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Adult participants who are: (a) greater than or equal to (>=) 65 years old or, (b)
18 to 64 years old and have at least 1 of the following:
1. Cumulative Illness Rating Scale (CIRS) score > 6
2. Creatinine clearance (CrCl) estimated less than (<) 70 milliliter per minute
(mL/min) using Cockcroft-Gault equation
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- Measurable nodal disease (by computed tomography [CT]), defined as at least one
lymph node > 1.5 centimeter (cm) in longest diameter
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or
equal to (<=) 2
- Active CLL/SLL requiring treatment per the iwCLL criteria
- Adult participants who are: (a) greater than or equal to (>=) 65 years old or, (b)
18 to 64 years old and have at least 1 of the following:
1. Cumulative Illness Rating Scale (CIRS) score > 6
2. Creatinine clearance (CrCl) estimated less than (<) 70 milliliter per minute
(mL/min) using Cockcroft-Gault equation
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- Measurable nodal disease (by computed tomography [CT]), defined as at least one
lymph node > 1.5 centimeter (cm) in longest diameter
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or
equal to (<=) 2
- Active CLL/SLL requiring treatment per the iwCLL criteria
- Prior anti-leukemic therapy for CLL or SLL
- Presence of deletion of the short arm of chromosome 17 (del17p) or known TP53
mutation detected at a threshold of >10 percent (%) variable allele frequency (VAF)
- Major surgery within 4 weeks of first dose of study treatment
- Known bleeding disorders (example, von Willebrand's disease or hemophilia)
- Central nervous system (CNS) involvement or suspected Richter's syndrome