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

NCT02717624

Active Not RecruitingPhase 1

Sponsor: Acerta Pharma BV

Conditions: Mantle Cell Lymphoma (MCL)

Interventions: Acalabrutinib in combination with BR, Acalabrutinib in combination with VR

Countries: United States, Italy, Poland

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (15)
  • Louisville, Kentucky, United States
  • Ann Arbor, Michigan, United States
  • Hackensack, New Jersey, United States
  • Morristown, New Jersey, United States
  • Lake Success, New York, United States
  • Columbus, Ohio, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • Seattle, Washington, United States
  • Bologna, Italy
  • Krakow, Poland
  • Lodz, Poland
  • Olsztyn, Poland
  • Warsaw, Poland