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ACTIVE NOT RECRUITING Phase 3

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

NCT04965493 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

Interventions

  • DRUG Venetoclax
  • DRUG Rituximab
  • DRUG Pirtobrutinib

Study Locations (20)

California

  • University of California Irvine Medical Center — Orange
  • Scripps Mercy Hospital — San Diego
  • Providence Medical Foundation — Santa Rosa

Florida

  • Florida Cancer Specialists — Fort Myers
  • Cancer Specialists of North Florida -St Augustine — Saint Augustine
  • Florida Cancer Specialists East — West Palm Beach

Arizona

  • Ironwood Physicians, Ironwood Cancer and Research Centers — Chandler
  • Mayo Clinic Hospital — Phoenix

Michigan

  • St. Joseph Mercy Hospital — Ann Arbor
  • University of Michigan — Ann Arbor

New York

  • The Mount Sinai Hospital — New York
  • Columbia University Medical Center — New York

Connecticut

  • Stamford Hospital — Stamford

Iowa

  • Mission Cancer and Blood — Des Moines

Kentucky

  • Pikeville Medical Center, Inc. — Pikeville

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2021-09-20
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 NCT04965493

The ClinicalTrials.gov registry entry for NCT04965493 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 600 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 Venetoclax 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: NCT04965493 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT04965493 about?

NCT04965493 is a clinical study titled "A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)". The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

What is the current status of trial NCT04965493?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2021-09-20. Estimated completion is 2027-10.

What conditions does trial NCT04965493 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 NCT04965493?

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

Who is sponsoring clinical trial NCT04965493?

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 NCT04965493 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Iowa. 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