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NCT05023980 · ClinicalTrials.gov registry record · Phase 3

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients 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.

Active
Registry status
Phase 3
Development phase
309
Enrollment target
20
Study locations

NCT05023980: Active Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Loxo Oncology.

NCT05023980 is a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is active but no longer recruiting, run by Loxo Oncology. The registered enrollment target is 309 participants, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (72% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05023980, a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by Loxo Oncology.

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

Study Summary

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.

Primary Outcome

Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria

Conditions Studied

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Interventions

  • DRUG Rituximab
  • DRUG Pirtobrutinib
  • DRUG Bendamustine

Study Locations (20)

Other

  • Uniklinikum Salzburg - Salzburg
  • Klinik Ottakring - Vienna
  • UMHAT "Sveti Georgi" EAD - Plovdiv
  • UMHAT 'Sv. Ivan Rilski', EAD - Sofia
  • "SHATHD" EAD, Sofia - Sofia
  • UMHAT - Prof. Dr. Stoyan Kirkovich" AD - Stara Zagora

Rio Grande do Sul

  • Hospital de Clinicas de Porto Alegre - Porto Alegre
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre - Porto Alegre
  • Centro Gaucho Integrado - Mae de Deus Center - Porto Alegre

California

  • California Research Institute - Los Angeles
  • Innovative Clinical Research Institute - Whittier

New South Wales

  • Liverpool Hospital - Liverpool
  • Westmead Hospital - Wentworthville

São Paulo

  • Hemocentro Unicamp - Campinas
  • Fundação Doutor Amaral Carvalho - Jaú

Florida

  • Oncology-Hematology Associates of West Broward - Coral Springs

New Jersey

  • New Jersey Center for Cancer Research - Brick

New York

  • Clinical Research Alliance, Inc. - Westbury

Trial Details

FieldValue
Enrollment Target 309 participants
Start Date 2021-09-23
Est. Completion 2027-10
Phase Phase 3
Loxo Oncology

14 total trials

What the registry record for NCT05023980 still lists

NCT05023980 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (72% higher).

The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.

NCT05023980 names 20 study sites across 10 states, led by Other, Rio Grande do Sul, California.

Frequently Asked Questions

What is clinical trial NCT05023980 about?

NCT05023980 is a clinical study titled "A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)". 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.

What is the current status of trial NCT05023980?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2021-09-23. Estimated completion is 2027-10.

What conditions does trial NCT05023980 study?

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

What interventions are being tested in trial NCT05023980?

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

Who is sponsoring clinical trial NCT05023980?

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

Where is trial NCT05023980 being conducted?

This trial has 20 study locations across California, Florida, New Jersey, New York, New South Wales. 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 NCT05023980's enrollment target sits among peer trials

309 27th of 187 higher than 161 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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Related registry views

Source: ClinicalTrials.gov NCT05023980, the US trial registry maintained by the National Library of Medicine. NCT05023980 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.