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ACTIVE NOT RECRUITING Phase 3

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

NCT04662255 · View on ClinicalTrials.gov ↗

Study Summary

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

Conditions Studied

Interventions

  • DRUG Zanubrutinib
  • DRUG Pirtobrutinib
  • DRUG Acalabrutinib
  • DRUG Ibrutinib

Study Locations (20)

Florida

  • Mayo Clinic in Florida — Jacksonville
  • Oncology-Hematology Associates of West Broward — Tamarac
  • Florida Cancer Specialists East — West Palm Beach

North Carolina

  • Messino Cancer Center — Asheville
  • Levine Cancer Institute — Charlotte
  • Wake Forest University School of Medicine — Winston-Salem

Kentucky

  • University of Kentucky Markey Cancer Center — Lexington
  • Mercy Health-Paducah Medical Oncology and Hematology — Paducah

New York

  • Columbia University Medical Center — New York
  • Memorial Sloan Kettering Cancer Center — New York

Alaska

  • Alaska Oncology and Hematology, LLC — Anchorage

Arizona

  • Arizona Oncology Associates, P.C. - HOPE — Phoenix

California

  • UCLA Medical Center — Los Angeles

Colorado

  • USO-Rocky Mountain Cancer Center — Denver

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2021-04-08
Est. Completion 2028-04
Phase Phase 3

Sponsor

Loxo Oncology

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04662255

The ClinicalTrials.gov registry entry for NCT04662255 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 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loxo Oncology, which has 35 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 Lymphoma, Mantle-Cell appearing as the primary indexed condition, and to 4 interventions — of which Zanubrutinib 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: NCT04662255 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Florida, North Carolina, Kentucky. 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 NCT04662255 about?

NCT04662255 is a clinical study titled "Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)". This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation ...

What is the current status of trial NCT04662255?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2021-04-08. Estimated completion is 2028-04.

What conditions does trial NCT04662255 study?

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

What interventions are being tested in trial NCT04662255?

The interventions under investigation include: Zanubrutinib (DRUG), Pirtobrutinib (DRUG), Acalabrutinib (DRUG), Ibrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04662255?

This trial is sponsored by Loxo Oncology, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04662255 being conducted?

This trial has 20 study locations across Alaska, Arizona, California, Colorado, Florida. 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