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OncoMatch/Clinical Trials/NCT06588478

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

Is NCT06588478 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pirtobrutinib for chronic lymphocytic leukemia.

Phase 2RecruitingLoxo Oncology, Inc.NCT06588478Data as of May 2026

Treatment: Pirtobrutinib — The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

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Extracted eligibility criteria

Cancer type

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Biomarker criteria

Required: TP53 17p deletion

Part 2 - Must have 17p deletion (positive)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 3 prior lines
Min 1 prior line

Must have received: BTK inhibitor

Have received a covalent BTK inhibitor

Cannot have received: BTK degrader

Have received prior treatment with a BTK degrader

Cannot have received: noncovalent BTK inhibitor

Have received prior treatment with a ... noncovalent BTK inhibitor

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Ironwood Cancer & Research Centers · Chandler, Arizona
  • City of Hope National Medical Center · Duarte, California
  • City of Hope National Medical Center · Irvine, California
  • Palo Alto Medical Foundation Research Institute (PAMFRI) · Palo Alto, California
  • Stanford Cancer Center · Palo Alto, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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