Clinical trial NCT02717624: A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Mantle Cell Lymphoma (MCL)
Keywords: Bruton Tyrosine Kinase Inhibitor
BTK
Mantle Cell Lymphoma
MCL
Acalabrutinib
ACE-LY-106
Lead sponsor: Acerta Pharma BV
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2016-03-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This is a multicenter, open-label Phase 1b study to assess the safety and efficacy of acalabrutinib when administered concomitantly with bendamustine and rituximab in subjects with treatment naive or relapse refractory mantle cell lymphoma (Part 1), or when administered concomitantly with venetoclax and rituximab in subjects with treatment naive mantle cell lymphoma (Part 2).

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.

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (AEs) as assessed by CTCAE v4.03
timeFrame: From first dose of study drug to within 30 days of last dose of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: Morristown
country: United States
facility: Research Site
state: New Jersey
city: Lake Success
country: United States
facility: Research Site
state: New York
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Bologna
country: Italy
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
Study officials:
affiliation: 1-888-292-9613; acertamc@dlss.com
name: Acerta Clinical Trials
role: STUDY_DIRECTOR
References: