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A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)

NCT04529772 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 611

Last updated 2026-03-31

No results posted yet for this study

Summary

Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DRUG

acalabrutinib

Investigational Product

DRUG

placebo

Placebo comparator

DRUG

Prednisone

Investigational Product

DRUG

Rituximab

Investigational Product

DRUG

Cyclophosphamide

Investigational Product

DRUG

Vincristine

Investigational Product

DRUG

Doxorubicin

Investigational Product

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Acerta Pharma BV

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2027-02-22
Completion
2027-02-22
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

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 NCT04529772 on ClinicalTrials.gov