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NCT04662255 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Lymphoma, Mantle-Cell, sponsored by Loxo Oncology.

Active
Registry status
Phase 3
Development phase
500
Enrollment target
20
Study locations

NCT04662255 is a Phase 3 study of Lymphoma, Mantle-Cell that is active but no longer recruiting, run by Loxo Oncology. The registered enrollment target is 500 participants, above the 165-participant average among 7 other Lymphoma, Mantle-Cell trials with a reported enrollment target (203% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04662255, a Phase 3 study of Lymphoma, Mantle-Cell, is active but no longer recruiting, sponsored by Loxo Oncology.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
500 participants
Enrollment target
20
Study locations

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

Lymphoma, Mantle-Cell

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

14 total trials

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What the Registry Record Tells You About NCT04662255

The ClinicalTrials.gov registry entry for NCT04662255 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 165-participant average among 7 other Lymphoma, Mantle-Cell trials with a reported enrollment target (203% higher). The listed sponsor is Loxo Oncology, which has 14 total studies on file at ClinicalTrials.gov.

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.

NCT04662255 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, North Carolina, Kentucky.

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.

What interventions are being tested in trial NCT04662255?

The interventions under investigation include: Zanubrutinib (DRUG), Pirtobrutinib (DRUG), Acalabrutinib (DRUG), Ibrutinib (DRUG).

Who is sponsoring clinical trial NCT04662255?

This trial is sponsored by Loxo Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.