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Clinical Trials in Poland / NCT02717624
Active, not recruiting Phase 1

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

NCT02717624 · tracked via the Priya Life Science Poland tracker
Phase
Phase 1
Started
2016-04-20
Last updated
2026-07-14

Condition(s) studied

Mantle Cell Lymphoma (MCL)

Investigational drug(s) / intervention(s)

Acalabrutinib in combination with BR →Acalabrutinib in combination with VR →

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Research Site Louisville Kentucky
Research Site Ann Arbor Michigan
Research Site Hackensack New Jersey
Research Site Morristown New Jersey
Research Site Lake Success New York
Research Site Columbus Ohio
Research Site Nashville Tennessee
Research Site Houston Texas
Research Site Seattle Washington
Research Site Seattle Washington
Research Site Bologna Italy
Research Site Krakow Poland
Research Site Lodz Poland
Research Site Olsztyn Poland
Research Site Warsaw Poland

More Acerta Pharma BV trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02717624 on ClinicalTrials.gov ↗ ← All trials in Poland