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NCT06973187 | RECRUITING | Chronic Lymphocytic Leukemia

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
Sponsor:

BeOne Medicines

Brief Summary:

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).

Condition or disease

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Intervention/treatment

BGB-16673

Pirtobrutinib

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 500 participants
Masking : NONE
Primary Purpose : TREATMENT
Official 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
Actual Study Start Date : 2025-09-04
Estimated Primary Completion Date : 2028-04-17
Estimated Study Completion Date : 2028-04-17

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
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

Location Details

NCT06973187

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Cancer Specialists of North Florida

Jacksonville, florida, United States, 001625

RECRUITING

United States, Missouri

Washington University School of Medicine

St Louis, Missouri, United States, 63110-1010

RECRUITING

United States, Ohio

Dayton Physician Network

Dayton, Ohio, United States, 45415

RECRUITING

United States, Virginia

Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)

Roanoke, Virginia, United States, 24014

RECRUITING

United States, Washington

Summit Cancer Centers

Spokane, Washington, United States, 99208-1129

RECRUITING

United States, Washington

Northwest Medical Specialties

tacoma, Washington, United States, 98405

RECRUITING

Australia, New South Wales

Concord Repatriation General Hospital

Concord, New South Wales, Australia, NSW 2139

RECRUITING

Australia, Queensland

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, Australia, QLD 4575

RECRUITING

Australia, Victoria

Peninsula Private Hospital

Frankston, Victoria, Australia, VIC 3199

RECRUITING

Australia, Victoria

Cabrini Hospital Malvern

Malvern East, Victoria, Australia, VIC 3144

RECRUITING

Australia, Victoria

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia, VIC 3000

RECRUITING

Australia, Victoria

The Alfred Hospital

Melbourne, Victoria, Australia, VIC 3004

RECRUITING

Australia, Western Australia

Linear Clinical Research

Nedlands, Western Australia, Australia, WA 6009

RECRUITING

New Zealand,

North Shore Hospital

Auckland, New Zealand, 0622

RECRUITING

New Zealand,

Tauranga Hospital

Tauranga, New Zealand, 3112

RECRUITING

Singapore,

Singapore General Hospital

Singapore, Singapore, 168582

RECRUITING

Singapore,

Tan Tock Seng Hospital Haematology

Singapore, Singapore, 308433