OncoMatch/Clinical Trials/NCT05254743
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Is NCT05254743 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Pirtobrutinib and Ibrutinib for chronic lymphocytic leukemia.
Treatment: Pirtobrutinib · Ibrutinib — The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: TP53 deletion of 17p
Part 2 - Must have deletion of 17p as determined by FISH testing
Required: TP53 wild-type
Part 1 - Known 17p deletion status (wildtype or deleted)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: btk inhibitor
Lab requirements
Blood counts
Platelets ≥ 50 x 10⁹/L (or ≥30 x 10⁹/L with marrow involvement); Hemoglobin ≥8 g/dL (or ≥6 g/dL with marrow involvement); Absolute neutrophil count ≥0.75 x 10⁹/L (or ≥0.50 × 10⁹/L with marrow involvement)
Kidney function
Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
Adequate organ function: Platelets ≥ 50 x 10⁹/L or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis, Hemoglobin ≥8 g/dL or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis, Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis, Kidney function: Estimated creatinine clearance ≥30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Pacific Cancer Medical Center, Inc · Anaheim, California
- TOI Clinical Research · Cerritos, California
- Stanford School of Medicine-Cancer Clinical Trials Office · Palo Alto, California
- California Cancer Associates for Research and Excellence · San Marcos, California
- Florida Cancer Specialists · Fort Myers, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05254743 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior btk inhibitor disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 deletion of 17p is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify