A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
A 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
2 other identifiers
interventional
72
3 countries
15
Brief Summary
A 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2016
Longer than P75 for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedStudy Start
First participant enrolled
April 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2027
ExpectedApril 20, 2026
April 1, 2026
6.2 years
February 24, 2016
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Treatment Emergent Adverse Events (AEs) as assessed by CTCAE v4.03
Number of participants who had experienced at least one treatment emergent AE
From first dose of study drug to within 30 days of last dose of study drug
Study Arms (3)
Part 1: Acalabrutinib+BR in TN patients
EXPERIMENTALPart 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients
Part 1: Acalabrutinib+BR in RR patients
EXPERIMENTALPart 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients
Part 2: Acalabrutinib+VR in TN patients
EXPERIMENTALPart 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecacollaborator
- Acerta Pharma BVlead
Study Sites (15)
Research Site
Louisville, Kentucky, 40207, United States
Research Site
Ann Arbor, Michigan, 48109, United States
Research Site
Hackensack, New Jersey, 07601, United States
Research Site
Morristown, New Jersey, 07960, United States
Research Site
Lake Success, New York, 11042, United States
Research Site
Columbus, Ohio, 43210, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Seattle, Washington, 98109, United States
Research Site
Seattle, Washington, 98122, United States
Research Site
Bologna, 40138, Italy
Research Site
Krakow, 30-510, Poland
Research Site
Lodz, 93-510, Poland
Research Site
Olsztyn, 10-228, Poland
Research Site
Warsaw, 02-106, Poland
Related Publications (1)
Wang M, Robak T, Maddocks KJ, Phillips T, Smith SD, Gallinson D, Calvo R, Wun CC, Munugalavadla V, Jurczak W. Acalabrutinib plus venetoclax and rituximab in treatment-naive mantle cell lymphoma: 2-year safety and efficacy analysis. Blood Adv. 2024 Sep 10;8(17):4539-4548. doi: 10.1182/bloodadvances.2023012424.
PMID: 38781315DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Acerta Clinical Trials
1-888-292-9613; acertamc@dlss.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2016
First Posted
March 24, 2016
Study Start
April 20, 2016
Primary Completion
June 15, 2022
Study Completion (Estimated)
August 20, 2027
Last Updated
April 20, 2026
Record last verified: 2026-04