Acalabrutinib, Bendamustine, Rituximab or Venetoclax for Mantle Cell Lymphoma Treatment
Acalabrutinib in combination with BR
+ Acalabrutinib in combination with VR
Maladies hématologiques et lymphatiques+7
+ Maladies du Système Immunitaire
+ Troubles immunoprolifératifs
Étude thérapeutique
Résumé
Date de début de l'étude : 20 avril 2016
Date à laquelle le premier participant a commencé l'étude.This clinical trial is a Phase 1b study that aims to evaluate the safety and effectiveness of a drug called acalabrutinib. The study involves two parts. In the first part, acalabrutinib is given in combination with bendamustine and rituximab to individuals with mantle cell lymphoma, a type of cancer that affects the lymph nodes. This part includes those who have not received treatment before or those whose cancer has come back or has not responded to treatment. In the second part, acalabrutinib is given with venetoclax and rituximab to individuals who have not received treatment for their mantle cell lymphoma. The goal of this study is to find new treatment options that could improve care for people with this condition. During the study, participants will receive their assigned treatment combination. The study will keep track of any side effects or adverse events that occur during the treatment period. The primary outcome being measured is the number of participants who experience at least one treatment-related adverse event. This information is important to understand the safety profile of these treatment combinations and to determine if they are well tolerated.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.72 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Men and women ≥ 18 years of age. * Pathologically confirmed MCL. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Agreement to use highly effective forms of contraception during the study and for 2 days after the last dose of acalabrutinib, 30 days after the last dose of venetoclax, or 12 months after the last dose of rituximab, whichever is longest. * Treatment Naive MCL patients requiring treatment with no exposure to prior therapies. Exclusion Criteria: * Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study * Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass * Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug * Breastfeeding or pregnant * Concurrent participation in another therapeutic clinical trial.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalGroupe III
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 15 sites
Research Site
Ann Arbor, United StatesResearch Site
Hackensack, United StatesResearch Site
Morristown, United States