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ACTIVE NOT RECRUITING Phase 3

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

NCT04529772 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Cyclophosphamide
  • DRUG placebo
  • DRUG Rituximab
  • DRUG Prednisone
  • DRUG acalabrutinib

Study Locations (20)

Florida

  • Research Site — Fort Myers
  • Research Site — Orlando
  • Research Site — St. Petersburg
  • Research Site — Tallahassee
  • Research Site — West Palm Beach

New York

  • Research Site — Albany
  • Research Site — New York

Arizona

  • Research Site — Tucson

Arkansas

  • Research Site — Little Rock

California

  • Research Site — Irvine

Colorado

  • Research Site — Aurora

Connecticut

  • Research Site — Norwich

Indiana

  • Research Site — Fort Wayne

Trial Details

FieldValue
Enrollment Target 611 participants
Start Date 2020-10-08
Est. Completion 2027-02-01
Phase Phase 3

Sponsor

Acerta Pharma

17 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04529772

The ClinicalTrials.gov registry entry for NCT04529772 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 611 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acerta Pharma, which has 17 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04529772 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, New York, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04529772 about?

NCT04529772 is a clinical study titled "A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)". 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 ...

What is the current status of trial NCT04529772?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 611 participants. The study started on 2020-10-08. Estimated completion is 2027-02-01.

What conditions does trial NCT04529772 study?

This clinical trial studies the following conditions: Diffuse Large B-Cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04529772?

The interventions under investigation include: Cyclophosphamide (DRUG), placebo (DRUG), Rituximab (DRUG), Prednisone (DRUG), acalabrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04529772?

This trial is sponsored by Acerta Pharma, which has 17 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04529772 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial