Who is eligible for clinical trial NCT04529772?

Participants must meet the protocol's inclusion criteria for Diffuse Large B-Cell Lymphoma. The stated age range is 18 Years to 75 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04529772 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-24

A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) (NCT04529772)

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Acerta Pharma BV

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (13 items).

Location: Research Site — Tucson, Arizona

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (243 Sites)

Showing the first 25 of 243 sites.

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗