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

NCT02972840 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 635

Last updated 2026-02-18

No results posted yet for this 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.

Conditions

  • Lymphoma, Mantle Cell

Interventions

DRUG

Acalabrutinib

Administered orally (PO)

DRUG

Bendamustine

Administered intravenously (IV)

DRUG

Rituximab

Administered intravenously (IV)

DRUG

Placebo

Placebo comparator

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Acerta Pharma BV

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2027-02-15
Completion
2027-02-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • New Zealand
  • Peru
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02972840 on ClinicalTrials.gov