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RECRUITING Phase 3

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

NCT05254743 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Loxo Oncology

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05254743

The ClinicalTrials.gov registry entry for NCT05254743 describes a study currently listed as 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 662 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 4 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions — of which Pirtobrutinib 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: NCT05254743 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Louisiana. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05254743?

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

Who is sponsoring clinical trial NCT05254743?

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 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.

Related

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