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 (CaDAnCe-302)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Lymphocytic Leukemia; CLL
• Intervention / Treatment: Drug: Rituximab; Drug: Bendamustine; Drug: Venetoclax; Drug: BGB-16673; Drug: Idelalisib

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."

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1.877.828.5568; Email: clinicaltrials@beonemed.com

Study Locations

• Argentina
  • CABA, Argentina, 1425
    • Recruiting
    • Hospital Alemán
  • Caba, Argentina, CP1114
    • Recruiting
    • FUNDALEU
  • Ciudad Autonoma Buenos Aires, Argentina, 1413
    • Recruiting
    • Hospital Italiano de Buenos Aires
  • Ciudad Autonoma Buenos Aires, Argentina, 1426
    • Recruiting
    • Instituto Alexander Fleming (Iaf)
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, NSW 2139
      • Recruiting
      • Concord Repatriation General Hospital
    • Gosford, New South Wales, Australia, NSW 2250
      • Recruiting
      • Gosford Hospital
    • Port Macquarie, New South Wales, Australia, NSW 2444
      • Recruiting
      • Port Macquarie Base Hospital
  • Queensland
    • Toowoomba, Queensland, Australia, QLD 4350
      • Recruiting
      • Toowoomba Hospital
  • Victoria
    • Melbourne, Victoria, Australia, VIC 3004
      • Recruiting
      • The Alfred Hospital
  • Western Australia
    • West Perth, Western Australia, Australia, WA 6005
      • Recruiting
      • Perth Blood Institute
• Brazil
  • Belo Horizonte, Brazil, 30110-022
    • Recruiting
    • CETUS
  • Brasília, Brazil, 70200-730
    • Recruiting
    • Hospital Sirio Libanes Brasilia
  • Curitiba, Brazil, 81520-060
    • Recruiting
    • Hospital Erasto Gaertner
  • Florianópolis, Brazil, 88020-210
    • Recruiting
    • Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
  • Joinville, Brazil, 89201-260
    • Recruiting
    • Instituto Joinvilense de Hematologia e Oncologia
  • Niterói, Brazil, 24020-096
    • Recruiting
    • Complexo Hospitalar de Niteroi
  • Porto Alegre, Brazil, 90110-270
    • Recruiting
    • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
  • Recife, Brazil, 52011-906
    • Recruiting
    • Hospital Santa Joana Recife
  • Rio de Janeiro, Brazil, 22250-040
    • Recruiting
    • Oncoclinicas Rio de Janeiro Sa
  • Rio de Janeiro, Brazil, 22061-080
    • Recruiting
    • Hospital Sao Lucas Dasa Oncologia
  • Salvador, Brazil, 41253-190
    • Recruiting
    • Hospital Sao Rafael (Rede Dor)
  • São Paulo, Brazil, 05652-900
    • Recruiting
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 04014-002
    • Recruiting
    • Instituto Brasileiro de Controle Do Cancer
  • São Paulo, Brazil, 01401-004
    • Recruiting
    • Instituto Dor de Pesquisa E Ensino Sao Paulo
  • Vitória, Brazil, 29043-260
    • Recruiting
    • Hospital Santa Rita de Cassia Afecc
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital Cancer Centre
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Recruiting
      • Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
    • Montreal, Quebec, Canada, QC H3t 1E2
      • Recruiting
      • Jewish General Hospital
• Czechia
  • Brno, Czechia, 625 00
    • Recruiting
    • Fakultni nemocnice Brno
  • Hradec Králové, Czechia, 500 03
    • Recruiting
    • Fakultni Nemocnice Hradec Kralove
  • Ostrava, Czechia, 708 00
    • Recruiting
    • Fakultni Nemocnice Ostrava
  • Prague, Czechia, 10000
    • Recruiting
    • Vseobecna Fakultni Nemocnice V Praze
• Germany
  • Augsburg, Germany, 86156
    • Recruiting
    • Universitätsklinikum Augsburg
  • Berlin, Germany, 10715
    • Recruiting
    • Praxis am Volkspark
  • Chemnitz, Germany, 09116
    • Recruiting
    • Klinikum Chemnitz gGmbH
  • Essen, Germany, 45122
    • Recruiting
    • Universitatsklinikum Essen (Aor)
  • Frankfurt am Main, Germany, 60389
    • Recruiting
    • Centrum Fur Haematologie Und Onkologie Bethanien
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I
  • Hamburg, Germany, 20251
    • Recruiting
    • Universitatsklinikum Hamburg Eppendorf
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitätsklinikum Heidelberg
  • Homburg, Germany, 66421
    • Recruiting
    • Saarland University Medical Center
  • Koblenz, Germany, 56068
    • Recruiting
    • InVO Institut für Versorgungsforschung in der Onkologie
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitaetsklinikum Leipzig Aor
  • Münster, Germany, 48149
    • Recruiting
    • Universitatsklinikum Munster Medizinische Klinik A
• Italy
  • Bari, Italy, 70124
    • Recruiting
    • IRCCS Istituto Tumori Giovanni Paolo II
  • Florence, Italy, 50134
    • Recruiting
    • Aou Careggi, Servizio Sanitario Toscana
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • Milan, Italy, 20122
    • Recruiting
    • Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
  • Naples, Italy, 80131
    • Recruiting
    • Azienda Ospedaliera Universitaria Federico II
  • Novara, Italy, 28100
    • Recruiting
    • AOU Maggiore della Carità
  • Pavia, Italy, 27100
    • Recruiting
    • IRCCS Policlinico San Matteo, Università degli studi di Pavi
  • Perugia, Italy, 6129
    • Recruiting
    • Ospedale Santa Maria Della Misericordia
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli
• Japan
  • Kumamoto, Japan, 860-8556
    • Recruiting
    • Kumamoto University Hospital
  • Okayama, Japan, 701-1192
    • Recruiting
    • National Hospital Organization Okayama Medical Center
  • Osaka, Japan, 545-8586
    • Recruiting
    • Osaka Metropolitan University Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Recruiting
      • Aichi Cancer Center Hospital Clinical Oncology
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Recruiting
      • NHO Shikoku Cancer Center
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 730-8619
      • Recruiting
      • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 064-0804
      • Recruiting
      • Aiiku Hospital
  • Hyōgo
    • AmagasakiCity, Hyōgo, Japan, 660-8550
      • Recruiting
      • Hyogo Prefectural Amagasaki General Medical Center
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 890-8520
      • Recruiting
      • Kagoshima University Hospital
  • Kyoto
    • KyotoShi, Kyoto, Japan, 602-8566
      • Recruiting
      • University Hospital, Kyoto Prefectural Univ of Medicine
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Recruiting
      • Tohoku University Hospital
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Recruiting
      • Niigata University Medical And Dental Hospital
  • Okayama-ken
    • Kurashikishi, Okayama-ken, Japan, 710-8602
      • Recruiting
      • Kurashiki Central Hospital
  • Osaka
    • Hirakata, Osaka, Japan, 573-1191
      • Recruiting
      • Kansai Medical University Hospital
    • Sakai, Osaka, Japan, 590-0197
      • Recruiting
      • Kindai University Hospital
  • Saitama
    • Kawagoeshi, Saitama, Japan, 350-8550
      • Recruiting
      • Saitama Medical Center
  • Tokyo
    • Shinagawaku, Tokyo, Japan, 141-0022
      • Recruiting
      • NTT Medical Center Tokyo
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • Amsterdam Umc Vu Mc
• Poland
  • Brzozów, Poland, 36-200
    • Recruiting
    • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
  • Katowice, Poland, 40-519
    • Recruiting
    • Pratia Onkologia Katowice
  • Krakow, Poland, 30-727
    • Recruiting
    • Pratia MCM Krakow
  • Lodz, Poland, 93-513
    • Recruiting
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
  • Lublin, Poland, 20-090
    • Recruiting
    • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
  • Wroclaw, Poland, 50-367
    • Recruiting
    • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
• South Korea
  • Busan Gwang'yeogsi
    • Seogu, Busan Gwang'yeogsi, South Korea, 49201
      • Recruiting
      • Dong A University Hospital
  • Daegu Gwang'yeogsi
    • Junggu, Daegu Gwang'yeogsi, South Korea, 41944
      • Recruiting
      • Kyungpook National University Hospital
  • Gyeonggi-do
    • IlsandongGu GoyangSi, Gyeonggi-do, South Korea, 10408
      • Recruiting
      • National Cancer Center (Korea)
  • Jeollanam-do
    • HwasunGun, Jeollanam-do, South Korea, 58128
      • Recruiting
      • Chonnam National University Hwasun Hospital
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
      • Recruiting
      • The Catholic University of Korea, Seoul St Marys Hospital
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 6500
    • Recruiting
    • Gazi University
  • Ankara, Turkey (Türkiye), 06200
    • Recruiting
    • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
  • Balçova, Turkey (Türkiye), 35330
    • Recruiting
    • Dokuz Eylül University
  • Dokuma, Turkey (Türkiye), 07025
    • Recruiting
    • Antalya Memorial Hospital
  • Sakarya, Turkey (Türkiye), 54100
    • Recruiting
    • Sakarya Training and Research Hospital
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Recruiting
    • Aberdeen Royal Infirmary
  • Birmingham, United Kingdom, B9 5SS
    • Recruiting
    • Birmingham Heartlands Hospital
  • Bournemouth, United Kingdom, BH7 7DW
    • Recruiting
    • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • Royal Marsden Hospital
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • University College Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • Southampton General Hospital
• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Recruiting
      • St Bernards Medical Center
  • California
    • Los Angeles, California, United States, 90095-3075
      • Recruiting
      • UCLA Department of Medicine Hematologyoncology
    • Whittier, California, United States, 90602
      • Recruiting
      • PIH Health Whittier Hospital
  • Colorado
    • Aurora, Colorado, United States, 80012-5405
      • Recruiting
      • Rocky Mountain Cancer Centers (Williams) Usor
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Recruiting
      • Florida Oncology and Hematology
    • Jacksonville, Florida, United States, 32207-8432
      • Recruiting
      • Baptist MD Anderson Cancer Center
    • Weston, Florida, United States, 33331-3609
      • Recruiting
      • Cleveland Clinic Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322-1013
      • Recruiting
      • Emory University Winship Cancer Institute
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Northside Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808-4365
      • Recruiting
      • Our Lady of the Lake Hospital
  • Maryland
    • Bethesda, Maryland, United States, 20817-7847
      • Recruiting
      • American Oncology Partners of Maryland Pa
  • Missouri
    • Springfield, Missouri, United States, 65807-5288
      • Recruiting
      • Oncology Hematology Associates
  • Nebraska
    • Omaha, Nebraska, United States, 68130-2042
      • Recruiting
      • Oncology Hematology West, PC dba Nebraska Cancer Specialists
  • New York
    • New York, New York, United States, 10065-6800
      • Recruiting
      • Memorial Sloan Kettering Cancer Center Mskcc
    • Westbury, New York, United States, 11590-5119
      • Recruiting
      • Clinical Research Alliance, Inc
  • Ohio
    • Cleveland, Ohio, United States, 44106-1716
      • Recruiting
      • University Hospitals
    • Dayton, Ohio, United States, 45415
      • Recruiting
      • Dayton Physician Network
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Oncology Associates of Oregon Willamette Valley Cancer Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • West Penn Hospital
    • York, Pennsylvania, United States, 17403-5049
      • Recruiting
      • Cancer Care Associates of York
  • Texas
    • Tyler, Texas, United States, 75702-7522
      • Recruiting
      • Texas Oncology Tyler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: BGB-16673 monotherapy; Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met	Drug: BGB-16673; Administered orally
Active Comparator: Arm B: Investigator's Choice; Participants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment.	Drug: Rituximab; Administered intravenously; Drug: Bendamustine; Administered intravenously; Drug: Venetoclax; Administered orally; Drug: Idelalisib; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) by Independent Review Committee (IRC)	PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).	Approximately 36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as time from the date of randomization to the date of death due to any cause.	Approximately 36 Months
Duration of Response (DOR) by IRC and Investigator Assessment	DOR is defined as the time from initial response to disease progression or death, whichever occurs first, as assessed by the IRC or by the investigator.	Approximately 36 Months
Progression-Free Survival (PFS) in Participants with Prior Exposure to Noncovalent Bruton Tyrosine Kinase Inhibitor(s) (ncBTKi) by IRC	PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 iwCLL for participants with prior exposure to ncBTKi.	Approximately 36 Months
PFS by the Investigator Assessment	PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by the investigator using modified 2018 iwCLL criteria for participants with CLL and Lugano classification for participants with SLL	Approximately 36 Months
Overall Response Rate (ORR) by IRC and Investigator Assessment	ORR is defined as the percentage of participants with best overall response of complete response (CR), complete response with incomplete bone marrow recovery (Cri), nodular partial remission (nPR), or partial response (PR) as assessed by the IRC or by the investigator.	Approximately 36 Months
Rate of Partial Response with Lymphocytosis (PR-L) or Higher Determined by IRC and by Investigator Assessment	Rate of PR-L or higher is defined as the percentage of participants with a best overall response of CR, CRi, nPR, PR, or PR-L as assessed by the IRC or by the Investigator	Approximately 36 Months
Time to Next Anti-CLL/SLL Treatment (TTNT)	TTNT is defined as the time from the date of randomization to the date of next anti-CLL/SLL treatment.	Approximately 36 Months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.	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	The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales(fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best). Higher scores in GHS and functional scales indicate better quality of life.	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	The symptom burden and physical condition will be measured by QLQ-CLL17. EORTC QLQ-CLL17 comprises 17 items grouped into 3 multi-item scales: 1) symptom burden, 2) physical condition/fatigue, and 3) worries/fears about health and functioning. Each question is rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much") and the recall period for all items is the past 7 days. The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. Higher scores represent higher levels of symptom burden, physical condition/fatigue, or worries/fears about health and functioning.	Approximately 24 Months

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2025
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): February 14, 2030

Study Registration Dates

• First Submitted: February 21, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CLL
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Acids, Acyclic; Carboxylic Acids; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Butyrates; Antibodies, Monoclonal, Murine-Derived; Bendamustine Hydrochloride; Rituximab; venetoclax; idelalisib
• Other Study ID Numbers: BGB-16673-302; 2024-518893-15-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No