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Study details
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A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Loxo Oncology, Inc.
NCT IDNCT05254743ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

662

Study length

about 5.5 years

Ages

18+

Locations

19 sites in CA, FL, LA +8

About this study

Researchers are testing whether pirtobrutinib, a treatment, is more effective than ibrutinib for people with CLL/SLL. The trial also tests if pirtobrutinib alone is effective in treating people with CLL/SLL who have not had previous treatment.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Ibrutinib
  • 2.Take Pirtobrutinib
PhasePhase 3
DrugIbrutinib
Routeoral
Primary goalPercentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 2

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low11%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

ibrutinib, pirtobrutinib

Drug routes

oral (Oral Tablet), oral

Endpoints

Primary: Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 2, Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1

Secondary: Comparative Tolerability, Duration of Response (DOR), Event-Free Survival (EFS), IRC-assessed Progression-Free Survival (PFS), Investigator assessed Progression-Free Survival (PFS), Overall Survival (OS), Percentage of Participants Achieving DOR Part 2, Time to Next Treatment (TTNT)

Body systems

Oncology