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

BeiGene

Status and phase: Begins enrollment this month; Phase 3

Conditions: CLL; Chronic Lymphocytic Leukemia

Treatments: Drug: Bendamustine; Drug: Rituximab; Drug: BGB-16673; Drug: Idelalisib; Drug: Venetoclax

Study type: Interventional

Funder types: Industry

Identifiers

NCT06846671

2024-518893-15-00 (EU Trial (CTIS) Number)

BGB-16673-302

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Full description

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.

In this study, participants with relapse/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab).

Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed diagnosis of CLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
2. Previously received treatment for CLL with a BTKi and BCL2i.
3. Measurable disease by computer tomography/magnetic resonance imaging
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Arm A: BGB-16673 monotherapy

Experimental group

Description:

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

Treatment:

Drug: BGB-16673

Arm B: Investigator's Choice

Active Comparator group

Description:

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

Treatment:

Drug: Venetoclax

Drug: Idelalisib

Drug: Rituximab

Drug: Bendamustine