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Clinical Trials in China / NCT02972840
Active, not recruiting Phase 3

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

NCT02972840 · tracked via the Priya Life Science China tracker
Sponsor
Acerta Pharma BV
Phase
Phase 3
Started
2017-04-05
Last updated
2026-06-01

Condition(s) studied

Lymphoma, Mantle Cell

Investigational drug(s) / intervention(s)

AcalabrutinibBendamustineRituximabPlacebo

Acalabrutinib: Administered orally (PO)

Bendamustine: Administered intravenously (IV)

Rituximab: Administered intravenously (IV)

Placebo: Placebo comparator

Study summary

This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

Eligibility

Sex
ALL
Min age
65 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Men and women, ≥ 65 years of age. * Pathologically confirmed MCL, with documentation of a chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5) . * MCL requiring treatment and for which no prior systemic anticancer therapies have been received. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Agreement to use highly effective forms of contraception during the study and 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest . Exclusion Criteria: * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec (calculated using Friderica's formula: QT/RR0.33) at screening. 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. * Concurrent participation in another therapeutic clinical trial.

Primary outcome measure(s)

Trial sites (228)

FacilityCityRegionStatus
Research Site Tucson Arizona
Research Site Downey California
Research Site Santa Monica California
Research Site New Haven Connecticut
Research Site Washington D.C. District of Columbia
Research Site Tallahassee Florida
Research Site West Palm Beach Florida
Research Site Marietta Georgia
Research Site Westwood Kansas
Research Site Louisville Kentucky
Research Site Ann Arbor Michigan
Research Site Rochester Minnesota
Research Site Kansas City Missouri
Research Site St Louis Missouri
Research Site Hackensack New Jersey
Research Site Morristown New Jersey
Research Site Hawthorne New York
Research Site Lake Success New York
Research Site Portland Oregon
Research Site Charleston South Carolina
Research Site Greenville South Carolina
Research Site Chattanooga Tennessee
Research Site Nashville Tennessee
Research Site Houston Texas
Research Site San Antonio Texas
Research Site Tyler Texas
Research Site Charlottesville Virginia
Research Site Fort Belvoir Virginia
Research Site Seattle Washington
Research Site Seattle Washington
Research Site Seattle Washington
Research Site Morgantown West Virginia
Research Site Buenos Aires Argentina
Research Site Buenos Aires Argentina
Research Site Buenos Aires Argentina
Research Site Buenos Aires Argentina
Research Site Caba Argentina
Research Site Córdoba Argentina
Research Site Bedford Park Australia
Research Site Concord Australia

+ 188 more sites — see the full list on the official registry below.

On this site

📄 Calquence (acalabrutinib) drug profile → 📄 Rituxan (rituximab) drug profile →

More Acerta Pharma BV trials in China

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 NCT02972840 on ClinicalTrials.gov ↗ ← All trials in China