Acalabrutinib, Bendamustine, Rituximab or Venetoclax for Mantle Cell Lymphoma Treatment
Acalabrutinib in combination with BR
+ Acalabrutinib in combination with VR
Hemic and Lymphatic Diseases+7
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: April 20, 2016
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.72 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
Research Site
Ann Arbor, United StatesResearch Site
Hackensack, United StatesResearch Site
Morristown, United States