A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL

Running, not enrolling · Phase 1

Conditions studied: Mantle Cell Lymphoma (MCL)

In brief

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

Key facts

Study ID

NCT02717624

Run by

Acerta Pharma BV

People needed

72

Starts

2016-04-20

Expected to finish

2027-08-20

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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