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ACTIVE NOT RECRUITING Phase 3

Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

NCT04666038 · View on ClinicalTrials.gov ↗

Study Summary

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

Interventions

  • DRUG Rituximab
  • DRUG Pirtobrutinib
  • DRUG Bendamustine
  • DRUG Idelalisib

Study Locations (20)

Florida

  • Boca Raton Regional Hospital — Boca Raton
  • Cancer Specialists of North Florida -St Augustine — Jacksonville
  • Oncology-Hematology Associates of West Broward — Tamarac

Kentucky

  • University of Kentucky Markey Cancer Center — Lexington
  • Norton Cancer Institute — Louisville
  • Mercy Health-Paducah Medical Oncology and Hematology — Paducah

Alabama

  • Southern Cancer Center, P.C. — Daphne
  • Mitchell Cancer Institute -University of South Alabama — Mobile

Arizona

  • Palo Verde Hematology Oncology — Glendale
  • Arizona Oncology Associates, P.C. - HOPE — Tucson

California

  • Orange Coast Memorial Medical Center — Fountain Valley
  • California Research Institute — Los Angeles

Illinois

  • Rush University Medical Center — Chicago
  • Illinois Cancer Specialists-Niles — Niles

Indiana

  • Community Health Network — Indianapolis
  • Arnett Cancer Center — Lafayette

Colorado

  • Rocky Mountain Cancer Center — Aurora

Trial Details

FieldValue
Enrollment Target 238 participants
Start Date 2021-03-09
Est. Completion 2027-05
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 NCT04666038

The ClinicalTrials.gov registry entry for NCT04666038 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 238 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 4 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: NCT04666038 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Kentucky, Alabama. 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 NCT04666038 about?

NCT04666038 is a clinical study titled "Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)". This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last...

What is the current status of trial NCT04666038?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 238 participants. The study started on 2021-03-09. Estimated completion is 2027-05.

What conditions does trial NCT04666038 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 NCT04666038?

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

Who is sponsoring clinical trial NCT04666038?

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 NCT04666038 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. 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