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 (May 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
Cancer type
Chronic Lymphocytic Leukemia
Acute Lymphoblastic Leukemia
Acute Myeloid 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 →
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