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

Phase 2

Recruiting

• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Interventions: Drug: Pirtobrutinib

• Registration Number: NCT06588478
• Lead Sponsor: Loxo Oncology, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Start: 2025-01-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Primary Completion: 2028-06
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pirtobrutinib Standard Dose (Dose 1)-Part 1	Pirtobrutinib	Pirtobrutinib administered orally.
Pirtobrutinib Dose 2-Part 1	Pirtobrutinib	Pirtobrutinib administered orally.
Pirtobrutinib Dose 3-Part 1	Pirtobrutinib	Pirtobrutinib administered orally.
Pirtobrutinib Standard Dose-Part 2	Pirtobrutinib	Pirtobrutinib administered orally.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	Baseline up to 3 years	Overall response rate is defined as the proportion of participants who achieve the best overall response at or before the initiation of subsequent anticancer therapy of CR, CRi, nPR, or PR. ORR will be assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 response criteria.

Secondary Outcome Measures

Name	Time	Method
Duration of Response	Baseline up to 3 years	Duration of response is defined as the time from the date of the first documented CR, CRi, nPR, or PR to disease progression (per iwCLL 2018) or death from any cause.

Trial Locations

Locations (135)

Ironwood Cancer & Research Centers; 🇺🇸 Chandler, Arizona, United States

City of Hope National Medical Center; 🇺🇸 Irvine, California, United States

Palo Alto Medical Foundation Research Institute (PAMFRI); 🇺🇸 Palo Alto, California, United States

Stanford Cancer Center; 🇺🇸 Palo Alto, California, United States

Rocky Mountain Cancer Center; 🇺🇸 Aurora, Colorado, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center; 🇺🇸 Miami, Florida, United States

City of Hope National Medical Center, Atlanta Cancer Center; 🇺🇸 Newnan, Georgia, United States

Mission Cancer + Blood; 🇺🇸 Waukee, Iowa, United States

Saint Elizabeth Medical Center Edgewood; 🇺🇸 Edgewood, Kentucky, United States

American Oncology Partners of Maryland, PA; 🇺🇸 Bethesda, Maryland, United States

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