Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING 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)

NCT05023980 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Loxo Oncology

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05023980

The ClinicalTrials.gov registry entry for NCT05023980 describes a study currently listed as active not 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 309 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 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Rituximab 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: NCT05023980 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Rio Grande do Sul, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05023980?

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

Who is sponsoring clinical trial NCT05023980?

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 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.

Related

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