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RecruitingPhase 3

A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

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 tests how well tacabrutideg (BGB-16673) works and how safe it is compared with treatment chosen by the study doctor. It is for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), two types of blood cancer, who have already received both BTK and BCL2 blocker medicines.

The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

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 standard guidelines.
  • Have received both BTK and BCL2 blockers for CLL or SLL.
  • If you have SLL, the cancer must be measurable on CT or MRI scans.
  • Be able to care for yourself and be out of bed or a chair for more than half of your waking hours (ECOG score 0–2).
  • Have liver function that meets the study’s requirements.
  • Have blood clotting function that meets the study’s requirements.

Who can't join

  • Have prolymphocytic leukemia, another type of blood cancer, or have had or may have Richter’s transformation, when CLL or SLL becomes a faster-growing cancer.
  • Had a stem cell transplant using your own cells or CAR-T therapy, which uses modified immune cells, within the past 3 months.
  • Have cancer involving the brain or spinal cord.
  • Have taken any BTK protein degrader, a medicine that breaks down the BTK protein.
  • Have an active fungal, bacterial, or viral infection needing treatment by injection or infusion that works throughout the body.
  • Have significant heart or blood vessel disease.

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

Official eligibility criteria

Inclusion Criteria: 1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria. 2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i. 3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 5. Adequate liver function 6. Adequate blood clotting function Exclusion Criteria: 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation 2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months 3. Known central nervous system involvement 4. Prior exposure to any BTK protein degraders 5. Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy 6. Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study sites (29)

AR

CA

CO

FL

GA

LA

MD

MI

MN

MO

MT

NE

  • Oncology Hematology West, Pc Dba Nebraska Cancer Specialists · Omaha, NE 68130-2042More trials in Omaha

NY

OH

OR

PA

TX