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NCT04666038 · ClinicalTrials.gov registry record · 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)

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

Active
Registry status
Phase 3
Development phase
238
Enrollment target
20
Study locations

NCT04666038 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 238 participants, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (31% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT04666038, 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
238 participants
Enrollment target
20
Study locations

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

14 total trials

What the Registry Record Tells You About NCT04666038

The ClinicalTrials.gov registry entry for NCT04666038 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (31% higher). The listed sponsor is Loxo Oncology, which has 14 total studies on file at ClinicalTrials.gov.

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.

NCT04666038 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Kentucky, Alabama.

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.

What interventions are being tested in trial NCT04666038?

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

Who is sponsoring clinical trial NCT04666038?

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

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.