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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 (Jun 2026). This Phase 2 trial studies Pirtobrutinib for chronic lymphocytic leukemia.

Phase 2RecruitingLoxo Oncology, Inc.NCT06588478Data as of Jun 2026Location: International · 18 countries

Treatment: PirtobrutinibThe 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

Treatments studied

Targeted therapy

Pirtobrutinib

Cancer type

Chronic Lymphocytic Leukemia

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 →

Frequently asked questions

Is NCT06588478 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior BTK degrader, noncovalent BTK inhibitor disqualifies patients from enrollment.

Does this trial require TP53?

Yes, TP53 17p deletion 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.

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