Trial comparing treatments for CLL
Official title 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
ClinicalTrials.gov ID: NCT06846671
What this study is testing
What is Tacabrutideg?
Tacabrutideg is an investigational oral medicine being studied as a potential treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how well tacabrutideg works and how safe it is compared to other treatments chosen by the doctor.
- Who it's for
- It is for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have already taken both BTK and BCL2 inhibitors.
- What's involved
- Participants will receive either tacabrutideg or a doctor‑chosen treatment such as idelalisib plus rituximab, bendamustine plus rituximab, or venetoclax plus rituximab. They will have regular visits and tests to monitor the disease and side effects.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
- Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
- Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Adequate liver function.
You likely can't join if
- Known prolymphocytic leukemia (defined per iwCLL 2018 as prolymphocytes comprising \>55% of peripheral blood lymphocytes), or currently suspected or...
- Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 6 months.
- Known central nervous system involvement.
- Prior exposure to any BTK protein degraders.
- Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy.
- Clinically significant cardiovascular disease.
See the full eligibility criteria
- Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
- Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
- Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Adequate liver function.
- Adequate blood clotting function.
- Known prolymphocytic leukemia (defined per iwCLL 2018 as prolymphocytes comprising \>55% of peripheral blood lymphocytes), or currently suspected or history of Richter's transformation within the last 5 years.
- Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 6 months.
- Known central nervous system involvement.
- Prior exposure to any BTK protein degraders.
- Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy.
- Clinically significant cardiovascular disease.
- Prior invasive fungal infection, except if patient agrees to receive secondary antifungal prophylaxis during the entire treatment period.
- Known contraindications to azole antifungal agents, including hypersensitivity reactions.
- Receiving systemic immunosuppressive therapy for a nonmalignant condition within 28 days before the first dose of study treatment. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Jonesboro, Arkansas, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Whittier, California, United States
- Aurora, Colorado, United States
- Golden, Colorado, United States
- Fort Myers, Florida, United States
- Jacksonville, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Baton Rouge, Louisiana, United States
- Bethesda, Maryland, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- Chesterfield, Missouri, United States
- Springfield, Missouri, United States
- Billings, Montana, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Shirley, New York, United States
+ 104 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Jonesboro, Arkansas, United States; Los Angeles, California, United States; San Diego, California, United States; Whittier, California, United States; Aurora, Colorado, United States; Golden, Colorado, United States and 118 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.