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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an IRC according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.

Conditions Studied

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

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
Loxo Oncology

14 total trials

What the registry record for NCT04666038 still lists

NCT04666038 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (31% higher).

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 names 20 study sites across 11 states, led by 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.

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 NCT04666038's enrollment target sits among peer trials

238 36th of 187 higher than 152 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 NCT04666038, the US trial registry maintained by the National Library of Medicine. NCT04666038 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.