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RECRUITING Phase 2

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

NCT06588478 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Loxo Oncology

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06588478

The ClinicalTrials.gov registry entry for NCT06588478 describes a study currently listed as recruiting. It is categorized as Phase 2, 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 249 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 1 intervention — of which Pirtobrutinib 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: NCT06588478 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Texas, 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06588478?

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

Who is sponsoring clinical trial NCT06588478?

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 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.

Related

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