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A Study of 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

NCT06846671 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-05-11

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

BGB-16673

Administered orally

DRUG

Bendamustine

Administered intravenously

DRUG

Idelalisib

Administered orally

DRUG

Rituximab

Administered intravenously

DRUG

Venetoclax

Administered orally

Sponsors & Collaborators

  • BeOne Medicines

    lead INDUSTRY

Principal Investigators

  • Study Director · BeOne Medicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2028-05-15
Completion
2030-02-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Czechia
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Poland
  • South Korea
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06846671 on ClinicalTrials.gov