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NCT06588478 · ClinicalTrials.gov registry record · Phase 2

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Loxo Oncology.

Recruiting
Registry status
Phase 2
Development phase
249
Enrollment target
20
Study locations

NCT06588478: Recruiting Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Loxo Oncology.

NCT06588478 is a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is actively recruiting participants, run by Loxo Oncology. The registered enrollment target is 249 participants, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06588478, a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is actively recruiting participants, sponsored by Loxo Oncology.

RECRUITING
Registry status
Phase 2
Development phase
249 participants
Enrollment target
20
Study locations

Study Summary

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Primary Outcome

Overall response rate is defined as the proportion of participants who achieve the best overall response at or before the initiation of subsequent anticancer therapy of CR, CRi, nPR, or PR. ORR will be assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 response criteria.

Conditions Studied

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Interventions

  • DRUG Pirtobrutinib

Study Locations (20)

California

  • City of Hope National Medical Center - Duarte
  • City of Hope National Medical Center - Irvine
  • Palo Alto Medical Foundation Research Institute (PAMFRI) - Palo Alto
  • Stanford Cancer Center - Palo Alto

Texas

  • USO-Texas Oncology-Central/South Texas - Austin
  • Sarah Cannon Research Institute/SCRI - The Woodlands

Arizona

  • Ironwood Cancer & Research Centers - Chandler

Colorado

  • Rocky Mountain Cancer Center - Aurora

Florida

  • University of Miami Hospital and Clinics, Sylvester Cancer Center - Miami

Georgia

  • City of Hope National Medical Center, Atlanta Cancer Center - Newnan

Iowa

  • Mission Cancer + Blood - Waukee

Kentucky

  • Saint Elizabeth Medical Center Edgewood - Edgewood

Trial Details

FieldValue
Enrollment Target 249 participants
Start Date 2025-01-03
Est. Completion 2028-12
Phase Phase 2
Loxo Oncology

14 total trials

What NCT06588478 shows while recruiting

NCT06588478 is an interventional study that assigns participants to a tested intervention. The registered 249 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 (38% higher).

The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Pirtobrutinib is the first listed.

NCT06588478 names 20 study sites across 16 states, led by California, Texas, Arizona.

Frequently Asked Questions

What is clinical trial NCT06588478 about?

NCT06588478 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma". The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhi...

What is the current status of trial NCT06588478?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 249 participants. The study started on 2025-01-03. Estimated completion is 2028-12.

What conditions does trial NCT06588478 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.

What interventions are being tested in trial NCT06588478?

The interventions under investigation include: Pirtobrutinib (DRUG).

Who is sponsoring clinical trial NCT06588478?

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

Where is trial NCT06588478 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. 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 NCT06588478's enrollment target sits among peer trials

249 34th of 187 higher than 154 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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More recruiting context for NCT06588478

Source: ClinicalTrials.gov NCT06588478, the US trial registry maintained by the National Library of Medicine. NCT06588478 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.