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

Recruiting now · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

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.

Key facts

Study ID

NCT06588478

Run by

Loxo Oncology, Inc.

People needed

249

Starts

2025-01-03

Expected to finish

2028-12-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.
• Part 1: Have received prior CLL/SLL treatment
• Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
• Have received a covalent BTK inhibitor
• Part 2: Have received no prior treatment for CLL/SLL
• Part 1 - Known 17p deletion status (positive or negative)
• Part 2 - Must have 17p deletion (positive)
• Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
• Capable of swallowing oral study medication.
• Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.

You may not qualify if…

• Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor
• Have a history of greater than or equal to (>=) Grade 3 bleeding due to treatment with a BTK inhibitor
• Have known or suspected Richter's transformation
• Have known or suspected history of central nervous system involvement by CLL/SLL
• Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:
• nonmelanoma skin cancer or lentigo malignant melanoma
• cervical carcinoma in situ
• localized prostate cancer undergoing active surveillance, and
• localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy

Where it is running

• City of Hope National Medical Center — Duarte, California, United States (enrolling)
• City of Hope National Medical Center — Irvine, California, United States (enrolling)
• Palo Alto Medical Foundation Research Institute (PAMFRI) — Palo Alto, California, United States (enrolling)
• Stanford Cancer Center — Palo Alto, California, United States (enrolling)
• Rocky Mountain Cancer Center — Aurora, Colorado, United States (enrolling)
• University of Miami Hospital and Clinics, Sylvester Cancer Center — Miami, Florida, United States (enrolling)
• City of Hope National Medical Center, Atlanta Cancer Center — Newnan, Georgia, United States (enrolling)
• Mission Cancer + Blood — Waukee, Iowa, United States (enrolling)
• Saint Elizabeth Medical Center Edgewood — Edgewood, Kentucky, United States (enrolling)
• American Oncology Partners, PA — Bethesda, Maryland, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• Gulfport Memorial Hospital — Gulfport, Mississippi, United States (enrolling)
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States (enrolling)
• East Carolina University — Greenville, North Carolina, United States (enrolling)
• Williamette Valley Cancer Institute & Research Center — Eugene, Oregon, United States (enrolling)
• Cancer Care Associates Of York — York, Pennsylvania, United States (enrolling)
• The West Clinic, PLLC dba West Cancer Center — Germantown, Tennessee, United States (enrolling)
• USO-Texas Oncology-Central/South Texas — Austin, Texas, United States (enrolling)
• Sarah Cannon Research Institute/SCRI — The Woodlands, Texas, United States (enrolling)
• USO-Virginia Oncology Associates — Hampton, Virginia, United States (enrolling)
• Flinders Medical Centre — Adelaide, Australia (enrolling)
• Bankstown-Lidcombe Hospital — Bankstown, Australia (enrolling)
• Box Hill Hospital — Box Hill, Australia (enrolling)
• Coffs Harbour Health Campus — Coffs Harbour, Australia (enrolling)
• Ironwood Cancer & Research Centers — Chandler, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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