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Active, not recruiting Phase 3 Interventional Results available

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

ClinicalTrials.gov ID: NCT05023980

Public ClinicalTrials.gov record NCT05023980. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 2, 2026, 3:13 PM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

Study identification

NCT ID
NCT05023980
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Loxo Oncology, Inc.
Industry
Enrollment
282 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 23, 2021 (Actual)
Primary completion
Jul 11, 2025 (Actual)
Completion
Oct 2027 (Estimated)
Last update posted
Sep 25, 2026

2021 – 2027

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
California Research Institute Los Angeles California 90027 —
Innovative Clinical Research Institute Whittier California 90603 —
Oncology-Hematology Associates of West Broward Coral Springs Florida 33065 —
New Jersey Center for Cancer Research Brick New Jersey 08724 —
Clinical Research Alliance, Inc. Westbury New York 11590 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 103 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05023980, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 25, 2026 · Synced Nov 2, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05023980 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →