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NCT05254743 · ClinicalTrials.gov registry record · Phase 3

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

A Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Loxo Oncology.

Recruiting
Registry status
Phase 3
Development phase
662
Enrollment target
20
Study locations

NCT05254743: Recruiting Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Loxo Oncology.

NCT05254743 is a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is actively recruiting participants, run by Loxo Oncology. The registered enrollment target is 662 participants, above the 178-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (272% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05254743, a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is actively recruiting participants, sponsored by Loxo Oncology.

RECRUITING
Registry status
Phase 3
Development phase
662 participants
Enrollment target
20
Study locations

Study Summary

The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.

Primary Outcome

ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria

Conditions Studied

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Leukemia, B-cell Leukemia, Lymphocytic

Interventions

  • DRUG Pirtobrutinib
  • DRUG Ibrutinib

Study Locations (20)

California

  • Pacific Cancer Medical Center, Inc - Anaheim
  • TOI Clinical Research - Cerritos
  • Stanford School of Medicine-Cancer Clinical Trials Office - Palo Alto
  • California Cancer Associates for Research and Excellence - San Marcos

Florida

  • Florida Cancer Specialists - Fort Myers
  • Cancer Specialists of North Florida -St Augustine - Saint Augustine
  • Florida Cancer Specialists East - West Palm Beach

Louisiana

  • Hematology Oncology Clinic - Baton Rouge
  • Tulane Cancer Center Office of Clinical Research - New Orleans

Texas

  • Kelsey Research Foundation - Houston
  • Lumi Research - Kingwood

Washington

  • Medical Oncology Associates, PS - Spokane
  • MultiCare Health System Institute for Research and Innovation - Spokane

Maryland

  • American Oncology Partners of Maryland, PA - Bethesda

Montana

  • St. Vincent Frontier Cancer Center - Billings

Pennsylvania

  • Cancer Care Associates of York - York

Trial Details

FieldValue
Enrollment Target 662 participants
Start Date 2022-07-22
Est. Completion 2028-01
Phase Phase 3
Loxo Oncology

14 total trials

What NCT05254743 shows while recruiting

NCT05254743 is an interventional study that assigns participants to a tested intervention. The registered 662 participants enrollment target is mid-sized for trials with a published cap, above the 178-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (272% higher).

The record links to 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Pirtobrutinib is the first listed.

NCT05254743 names 20 study sites across 12 states, led by California, Florida, Louisiana.

Frequently Asked Questions

What is clinical trial NCT05254743 about?

NCT05254743 is a clinical study titled "A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)". The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatm...

What is the current status of trial NCT05254743?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 662 participants. The study started on 2022-07-22. Estimated completion is 2028-01.

What conditions does trial NCT05254743 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Leukemia, B-cell, Leukemia, Lymphocytic.

What interventions are being tested in trial NCT05254743?

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

Who is sponsoring clinical trial NCT05254743?

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

Where is trial NCT05254743 being conducted?

This trial has 20 study locations across California, Florida, Louisiana, Maryland, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Chronic Lymphocytic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05254743's enrollment target sits among peer trials

662 10th of 187 higher than 178 of 187 other Chronic Lymphocytic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05254743

Source: ClinicalTrials.gov NCT05254743, the US trial registry maintained by the National Library of Medicine. NCT05254743 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.