🏛️ 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)

🔵 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

📋 "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).

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)

  • 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.
🏛️ View Official NIH Record ↗