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NCT Number: NCT06973187

A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

FUNDALEU, Caba, Argentina

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About this study

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria
  • Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi.
  • Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters.

Exclusion criteria

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation.
  • History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  • History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
  • Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi).
  • Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

BGB-16673

Drug

BGB-16673 will be administered orally

Pirtobrutinib

Drug

Pirtobrutinib will be administered orally

Other names: Jaypirca

Primary outcomes

  1. Progression-Free Survival (PFS) per Independent Review Committee (IRC)

    Time frame: Up to approximately 3 years

    PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 3 years

    OS is defined as the time from the date of randomization to the date of death due to any cause.

  2. PFS per Investigator (INV)

    Time frame: Up to approximately 3 years

    PFS per INV is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by investigator using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with CLL and Lugano classification for participants with SLL.

  3. Overall Response Rate (ORR) per IRC and INV

    Time frame: Up to approximately 3 years

    ORR is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, or partial response, as assessed by the investigator and IRC using modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL.

  4. Rate of Partial Response with Lymphocytosis (PR-L) or Higher per IRC and INV

    Time frame: Up to approximately 3 years

    The rate of PR-L or higher is defined as the percentage of participants with a best overall response of complete response, complete response with incomplete bone marrow recovery, nodular partial remission, partial response, or PR-L.

  5. Duration of Response (DOR) per IRC and INV

    Time frame: Up to approximately 3 years

    DOR is defined as the time from initial response to disease progression or death, whichever occurs first.

  6. Time to Next Anti-CLL/SLL Treatment (TTNT)

    Time frame: Up to approximately 3 years

    TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment.

  7. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 3 years

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities.

  8. Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire EORTC IL409

    Time frame: Baseline and up to approximately 3 years

    EORTC IL409 consists of a set of 19 questions derived from the EORTC quality of life questionnaire core 30 (QLQ-C30) and its CLL module CLL17. The EORTC IL409 includes questions on global health status (GHS)/quality of life, physical functioning, role functioning, physical condition/fatigue, and symptom burden.Higher scores in GHS and functional scales and lower scores in symptom scales indicate better health-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

1-877-828-5568

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 15, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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