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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares tacabrutideg alone with pirtobrutinib to see how safe they are and how well they work. It is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that came back or did not respond to treatment that included a covalent BTK inhibitor, a type of cancer drug.

The purpose of this study is to evaluate the efficacy and safety of tacabrutideg 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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed CLL or SLL that needs treatment under the study’s guidelines.
  • Have had at least one treatment that included a covalent BTK inhibitor, with cancer that came back or did not respond.
  • If you have SLL, a CT or MRI scan must show at least one lymph node larger than 1.5 cm at its longest point and measurable in two directions.

Who can't join

  • Have prolymphocytic leukemia, another type of blood cancer, or have had or may now have Richter’s transformation, when CLL/SLL changes into a faster-growing cancer.
  • Have a known bleeding disorder, such as hemophilia or von Willebrand disease, or have had bleeding without an injury that needed a blood transfusion or other medical care.
  • Had a stroke caused by a blocked blood vessel or bleeding inside the skull within 6 months before the first study dose.
  • Have ever taken a BTK protein degrader or a noncovalent BTK inhibitor, two types of cancer drugs.
  • Have or have had CLL/SLL in the brain, spinal cord, or the tissues or fluid around them.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (49)

AL

AZ

CA

DC

DE

FL

IA

IL

KS

LA

MA

MI

MN

MO

NC

NJ

NY

OH

PA

SC

TN

TX

VA

  • Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia) · Roanake, VA 24014More trials in Roanake

WA

WI