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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BGB-16673, Bendamustine, Idelalisib, Rituximab.
- Who it may be relevant to
- Registry conditions: CLL, Chronic Lymphocytic Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Brazil, Canada +9
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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 or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors
Overview
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).
Detailed 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 relapsed/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 (for CLL only) 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 or SLL 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.
"Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website."
Interventions
- Drug BGB-16673
Administered orally - Drug Bendamustine
Administered intravenously - Drug Idelalisib
Administered orally - Drug Rituximab
Administered intravenously - Drug Venetoclax
Administered orally
Primary outcome measures
- Progression-Free Survival (PFS) by Independent Review Committee (IRC) [Time frame: Approximately 36 Months]
Secondary outcome measures (10)
- Overall Survival (OS) [Time frame: Approximately 36 Months]
- Progression-Free Survival (PFS) in Participants with Prior Exposure to Noncovalent Bruton Tyrosine Kinase Inhibitor(s) (ncBTKi) by IRC [Time frame: Approximately 36 Months]
- PFS by the Investigator Assessment [Time frame: Approximately 36 Months]
- Overall Response Rate (ORR) by IRC and Investigator Assessment [Time frame: Approximately 36 Months]
- Rate of Partial Response with Lymphocytosis (PR-L) or Higher Determined by IRC and by Investigator Assessment [Time frame: Approximately 36 Months]
- Duration of Response (DOR) by IRC and Investigator Assessment [Time frame: Approximately 36 Months]
- Time to Next Anti-CLL/SLL Treatment (TTNT) [Time frame: Approximately 36 Months]
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [Time frame: Approximately 36 Months]
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire -Core 30 (EORTC QLQ-C30) Global Health Status/QoL (GHS) and Physical Functioning Scales [Time frame: Approximately 24 Months]
- Change from baseline in EORTC Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17) Symptom Burden and Physical Condition Scales [Time frame: Approximately 24 Months]
Eligibility criteria
Inclusion 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) score 0, 1, or 2
- Adequate liver function
- Adequate blood clotting function
Exclusion criteria
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 25 centers
- St Bernards Medical Center — Jonesboro
- UCLA Department of Medicine Hematologyoncology — Los Angeles
- Pih Health Whittier Hospital — Whittier
- Rocky Mountain Cancer Centers (Williams) Usor — Aurora
- Florida Oncology and Hematology — Fort Myers
- Baptist Md Anderson Cancer Center — Jacksonville
- Cleveland Clinic Florida — Weston
- Emory University Winship Cancer Institute — Atlanta
- … and 17 more centers
Japan · 18 centers
Center list to be confirmed — check the primary protocol.
Brazil · 15 centers
- CETUS — Belo Horizonte
- Hospital Sirio Libanes Brasilia — Brasília
- Hospital Erasto Gaertner — Curitiba
- Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen) — Florianópolis
- Instituto Joinvilense de Hematologia E Oncologia — Joinville
- Complexo Hospitalar de Niteroi — Niterói
- Centro Gaucho Integrado de Oncologia Hospital Mae de Deus — Porto Alegre
- Hospital Santa Joana Recife — Recife
- … and 7 more centers
Germany · 12 centers
- Universitatsklinikum Augsburg — Augsburg
- Praxis Am Volkspark — Berlin
- Klinikum Chemnitz Ggmbh — Chemnitz
- Universitatsklinikum Essen (Aor) — Essen
- Centrum Fur Haematologie Und Onkologie Bethanien — Frankfurt am Main
- Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I — Freiburg im Breisgau
- Universitatsklinikum Hamburg Eppendorf — Hamburg
- Universitatsklinikum Heidelberg — Heidelberg
- … and 4 more centers
Italy · 9 centers
- Irccs Istituto Tumori Giovanni Paolo Ii — Bari
- Aou Careggi, Servizio Sanitario Toscana — Florence
- Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico — Milan
- Ospedale San Raffaele — Milan
- Azienda Ospedaliera Universitaria Federico Ii — Naples
- … and 4 more centers
Australia · 8 centers
- Concord Repatriation General Hospital — Concord
- Gosford Hospital — Gosford
- Port Macquarie Base Hospital — Port Macquarie
- Prince of Wales Hospital — Randwick
- Toowoomba Hospital — Toowoomba
- Flinders Medical Centre — Bedford PK
- The Alfred Hospital — Melbourne
- Perth Blood Institute — West Perth
South Korea · 7 centers
Center list to be confirmed — check the primary protocol.
Argentina · 6 centers
- Hospital Aleman — CABA
- CEMIC — Caba
- FUNDALEU — Caba
- Hospital Italiano de Buenos Aires — Ciudad Autonoma Buenos Aires
- Instituto Alexander Fleming (Iaf) — Ciudad Autonoma Buenos Aires
- Cice 9 de Julio Sanatorio 9 de Julio — San Miguel de Tucumán
Poland · 6 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 6 centers
Center list to be confirmed — check the primary protocol.
Canada · 5 centers
- London Health Sciences Centre — London
- The Ottawa Hospital Cancer Centre — Ottawa
- Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre — Greenfield Park
- Jewish General Hospital — Montreal
- Unite de Recherche Clinique Du Cisss Des Laurentides — SaintJerome
Turkey (Türkiye) · 5 centers
Center list to be confirmed — check the primary protocol.
Czechia · 4 centers
- Fakultni Nemocnice Brno — Brno
- Fakultni Nemocnice Hradec Kralove — Hradec Králové
- Fakultni Nemocnice Ostrava — Ostrava
- Vseobecna Fakultni Nemocnice V Praze — Prague
Netherlands · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06846671 · BGB-16673-302 · 2024-518893-15-00