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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 662 participants |
| Start Date | 2022-07-22 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 662 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 178-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (272% higher). The listed sponsor is Loxo Oncology, which has 14 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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