A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
NCT ID: NCT02717624
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2016-04-20
2027-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Acalabrutinib+BR in TN patients
Part 1: Acalabrutinib in combination with drugs bendamustine and rituximab (BR) in treatment naive patients
Acalabrutinib in combination with BR
Part 1: Acalabrutinib+BR in RR patients
Part 1: Acalabrutinib in combination with bendamustine and rituximab (BR) in relapse refractory patients
Acalabrutinib in combination with BR
Part 2: Acalabrutinib+VR in TN patients
Part 2: Acalabrutinib in combination with venetoclax and rituximab (VR) in treatment naive patients
Acalabrutinib in combination with VR
Interventions
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Acalabrutinib in combination with BR
Acalabrutinib in combination with VR
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Acerta Pharma BV
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Research Site
Louisville, Kentucky, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Hackensack, New Jersey, United States
Research Site
Morristown, New Jersey, United States
Research Site
Lake Success, New York, United States
Research Site
Columbus, Ohio, United States
Research Site
Nashville, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Seattle, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Bologna, , Italy
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Olsztyn, , Poland
Research Site
Warsaw, , Poland
Countries
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References
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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.
Other Identifiers
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2023-509353-31-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACE-LY-106
Identifier Type: -
Identifier Source: org_study_id
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