Suspended

Acalabrutinib, Bendamustine, Rituximab or Venetoclax for Mantle Cell Lymphoma Treatment

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What is being tested

Acalabrutinib in combination with BR

+ Acalabrutinib in combination with VR

Drug
Who is being recruted

Hemic and Lymphatic Diseases+7

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2016
See protocol details

Summary

Principal SponsorAcerta Pharma BV
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Phase 1b, Multicenter, Open-label Study of Acalabrutinib in Combination With Bendamustine and Rituximab (BR) or Venetoclax and Rituximab (VR) in Subjects With Mantle Cell Lymphoma
NCT02717624
Principal SponsorAcerta Pharma BV
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, Mantle-Cell

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.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients

Group II

Experimental
Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients

Group III

Experimental
Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients

Study 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

Suspended

Research Site

Louisville, United StatesOpen Research Site in Google Maps
Suspended

Research Site

Ann Arbor, United States
Suspended

Research Site

Hackensack, United States
Suspended

Research Site

Morristown, United States
Suspended15 Study Centers