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Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 36 months

250 Participants Needed

BGB-16673 for Chronic Lymphocytic Leukemia

Recruiting at 120 trial locations

Overseen ByStudy Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: BeiGene

Disqualifiers: Richter's transformation, CNS involvement, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate the efficacy and safety of BGB-16673 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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug BGB-16673 for treating chronic lymphocytic leukemia?

The effectiveness of BGB-16673 for chronic lymphocytic leukemia may be supported by its potential role as a B-cell receptor signaling inhibitor, similar to other drugs like ibrutinib and idelalisib, which have shown significant activity in disrupting cancer cell growth and improving outcomes in CLL patients.¹ ² ³ ⁴ ⁵

What safety data exists for BGB-16673 or similar treatments for chronic lymphocytic leukemia?

BTK inhibitors, like ibrutinib and acalabrutinib, have been used to treat chronic lymphocytic leukemia and have known side effects. Ibrutinib can cause heart rhythm problems, bleeding, infections, and high blood pressure, while acalabrutinib may cause headaches, diarrhea, and infections. These treatments are generally well tolerated, but monitoring for side effects is important.² ⁶ ⁷ ⁸ ⁹

What makes the drug BGB-16673 unique for treating Chronic Lymphocytic Leukemia?

BGB-16673 is likely a novel drug targeting the B-cell receptor (BCR) signaling pathway, which is crucial for the survival and growth of leukemia cells in Chronic Lymphocytic Leukemia (CLL). This approach is similar to other BCR pathway inhibitors like ibrutinib, which have shown promise in disrupting leukemia cell migration and survival, offering a targeted treatment option distinct from traditional chemotherapy.¹ ² ³ ⁹ ¹⁰

Research Team

Study Director

Principal Investigator

BeiGene

Eligibility Criteria

This trial is for people with chronic lymphocytic leukemia (CLL) who have already been treated with BTK and BCL2 inhibitors. Participants should be in need of treatment due to disease progression after previous therapies.

Inclusion Criteria

I can take care of myself but may not be able to do heavy physical work.

Measurable disease by computer tomography/magnetic resonance imaging

My liver is working well.

See 3 more

Exclusion Criteria

I have or am suspected to have had a specific type of leukemia or its transformation.

I have had a stem cell transplant or CAR-T therapy in the last 3 months.

I have not been treated with BTK protein degraders before.

See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BGB-16673 or investigator's choice of treatment until treatment discontinuation criteria are met

Approximately 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 36 months

Treatment Details

Interventions

BGB-16673

Trial Overview The study compares the effectiveness and safety of a new drug, BGB-16673, against other chosen treatments combined with rituximab (either idelalisib, bendamustine, or venetoclax). Patients will randomly receive either the new drug or one of the standard options.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: BGB-16673 monotherapyExperimental Treatment1 Intervention

Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met

Group II: Arm B: Investigator's ChoiceActive Control4 Interventions

Participants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.

Find a Clinic Near You

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Findings from Research

BTK inhibitors (BTKis) have significantly improved treatment for chronic lymphocytic leukemia (CLL) by targeting Bruton's tyrosine kinase, which is crucial for B-cell receptor signaling, leading to reduced cell proliferation and activation of harmful pathways.

While BTKis like ibrutinib and acalabrutinib are effective, they come with notable long-term adverse effects, including cardiac issues and infections, highlighting the need for careful management of these side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing toxicities of Bruton tyrosine kinase inhibitors.Lipsky, A., Lamanna, N.[2023]

Bruton's tyrosine kinase inhibitor (ibrutinib) and phosphatidylinositol 3-kinase inhibitor (idelalisib) are effective and well-tolerated treatment options for chronic lymphocytic leukemia, especially in older patients who may struggle with traditional chemotherapy side effects.

While these B cell receptor inhibitors are promising, they come with specific side effects: ibrutinib can increase the risk of bleeding and atrial fibrillation, while idelalisib may cause transaminitis, diarrhea, and pneumonitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

B cell receptor inhibition as a target for CLL therapy.Jeyakumar, D., O'Brien, S.[2021]

Acalabrutinib, a next-generation BTK inhibitor, has shown improved safety and efficacy in treating chronic lymphocytic leukemia (CLL) compared to the first-in-class drug ibrutinib, with completed phase 3 trials demonstrating better outcomes for both relapsed/refractory and treatment-naive patients.

The drug selectively inhibits BTK with fewer off-target effects, and early studies suggest that combining acalabrutinib with other therapies, like a CD20 antibody and venetoclax, can lead to high rates of undetectable minimal residual disease in patients, indicating a potential for fixed-duration treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the pharmacokinetics of acalabrutinib in the treatment of chronic lymphocytic leukemia.Miao, Y., Xu, W., Li, J.[2022]