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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

What this study is about

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.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Ibrutinib
  • 2.Take Pirtobrutinib

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
OralOral

How treatment is administered

Treatment Assignment
Randomized (Open Label)

You are randomly assigned, but you will know your treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

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