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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
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2025-078
NCT ID
NCT06973187
Age Group
Adult
Scope
National
Phase
Phase III
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
Phase III
Principal Investigator
Jay
Yang, M.D.
Oncology - Hematology, Oncology - Medical
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Objective:
Primary Objectives:
To evaluate the efficacy of BGB-16673 compared to pirtobrutinib as measured by progression-free survival (PFS) determined by independent review committee (IRC)
Secondary Objectives:
To evaluate the efficacy of BGB-16673 compared to pirtobrutinib, as measured by overall survival (OS)
To further evaluate the efficacy of BGB-16673 compared to pirtobrutinib, as measured by additional efficacy endpoints
To evaluate the safety of BGB-16673 versus pirtobrutinib
To evaluate patient-reported disease and treatment-specific symptoms and functioning in patients receiving BGB-16673 versus pirtobrutinib
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
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
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Lymphoid Leukemia; Non-Hodgkin Lymphoma
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy
Drugs
BGB16673; Pirtobrutinib
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