ClinTrial Refer

Trial Acronym
BGB-16673-302

Registration Number
NCT06846671

Scientific Title
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 Previously Exposed to Both BTK and BCL2 Inhibitors

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).

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

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/

Trial Location Name

Address

Status

Alfred Health (Haematology)

The Alfred, Commercial Road, Melbourne VIC, Australia

Recruiting

Primary Contact : John Nguyen, john.nguyen@alfred.org.au , 03 9076 7135

Concord Repatriation General Hospital (Haematology)

Hospital Rd, Concord NSW 2139, Australia

Pending

Primary Contact : Jennifer Harman, SLHD-ConcordHaematologyClinicalResearch@health.nsw.gov.au , 02 9767 6348

BeiGene

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT06846671

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT06846671

Secondary IDs
2024-518893-15-00BGB-16673-302

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 3

Minimum Age
18

Maximum Age
100

Date Registered
21/02/2025

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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