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

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

A phase 2 trial of Pirtobrutinib in chronic lymphocytic leukaemia, run by Loxo Oncology, Inc., now recruiting.

Recruiting

Overview Taking part Connected5

Overview

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma is a phase 2 interventional study registered as NCT06588478 by Loxo Oncology, Inc., with 249 participants planned, started 2025-01-03 and due to reach its primary completion in 2028-06. Interventions recorded: Pirtobrutinib.

Setting

A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

Phase

Phase 2

Sponsor

Loxo Oncology, Inc.

Registry

Started

2025-01-03

Enrolled

249 enrolled

Taking part

NCT06588478recruiting

Run by: Loxo Oncology, Inc. with 1 collaborator
Open to: 18 Years and over, any sex
Enrolment: 249 (estimated)
Sites: 131, 131 recruiting
Countries: Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Romania, Slovakia, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Registry updated: 2026-05-19

The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.

ClinicalTrials.gov data courtesy of the US National Library of Medicine.

Connected

5

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cancers

Chronic lymphocytic leukaemia Relapsed or refractory chronic lymphocytic leukaemia

technologies

Small-molecule kinase inhibitors

drugs

ApprovedSmall-molecule non-covalent (reversible) BTK inhibitor

Pirtobrutinib · Jaypirca

companies

Eli Lilly (incl. Loxo)

Evidence strength32/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 2+15
249 enrolled+12
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

Make correction

Report a readout

Cancers

Chronic lymphocytic leukaemia
Relapsed or refractory chronic lymphocytic leukaemia

Technologies

Small-molecule kinase inhibitors

Products

Pirtobrutinib

Companies

Eli Lilly (incl. Loxo)

Sources

Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.

ClinicalTrials.gov · 1

ClinicalTrials.gov NCT06588478

A source that has moved or gone is reported by the weekly link check. /audit/

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sourced, not expert-reviewed

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