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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Diffuse Large B-Cell Lymphoma

In brief

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.

Key facts

Study ID: NCT04529772
Run by: Acerta Pharma BV
People needed: 611
Starts: 2020-10-08
Expected to finish: 2027-02-22
Last updated by the study team: 2026-06-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men and women, age ≥18 and ≤75 years
Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review.
No prior treatment for DLBCL
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
International Prognostic Index (IPI) score of 1 to 5
Disease Stage II to IV by the Ann Arbor Classification
Adequate organ and marrow function
Agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab

You may not qualify if…

Evidence of severe or uncontrolled systemic diseases
Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease)
History of stroke or intracranial haemorrhage in preceding 6 months.
Known CNS lymphoma or leptomeningeal disease
Known primary mediastinal lymphoma
Known High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Prior history of indolent lymphoma or CLL
History of or ongoing confirmed PML
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
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
Prior anthracycline use ≥150 mg/m2

Where it is running

Research Site — Little Rock, Arkansas, United States
Research Site — Irvine, California, United States
Research Site — Aurora, Colorado, United States
Research Site — Norwich, Connecticut, United States
Research Site — Fort Myers, Florida, United States
Research Site — Orlando, Florida, United States
Research Site — St. Petersburg, Florida, United States
Research Site — Tallahassee, Florida, United States
Research Site — West Palm Beach, Florida, United States
Research Site — Fort Wayne, Indiana, United States
Research Site — Des Moines, Iowa, United States
Research Site — Wichita, Kansas, United States
Research Site — Louisville, Kentucky, United States
Research Site — Baltimore, Maryland, United States
Research Site — Grand Rapids, Michigan, United States
Research Site — Minneapolis, Minnesota, United States
Research Site — St Louis, Missouri, United States
Research Site — Albany, New York, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — Stony Brook, New York, United States
Research Site — Charlotte, North Carolina, United States
Research Site — Winston-Salem, North Carolina, United States
Research Site — Eugene, Oregon, United States
Research Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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