Um estudo de escalonamento de dose e expansão de Fase 1 de BGB-16673 em pacientes com malignidades de células B (CaDAnCe-101)
Um estudo de Fase 1, Aberto, Escalação de Dose e Expansão do Degradador de Proteína BGB-16673 Direcionado à Tirosina Quinase Bruton em Pacientes com Malignidades de Células B
Study consists of two main parts to explore tacabrutideg recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
A B-cell malignancy is a type of cancer that starts in white blood cells called B-cells. These cancers can affect the lymph nodes, bone marrow, blood, spleen, and other organs. Examples of these cancers include chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma, follicular lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, and diffuse large B cell lymphoma.
Tacabrutideg is a type of medicine called a BTK degrader. BTK (Bruton's tyrosine kinase) is a protein that helps cancer cells survive. Tacabrutideg is designed to attach to the BTK protein and tag it for removal, so that the body's own cellular "clean-up" system breaks it down and clears it away. When more BTK is removed from the body, it interferes with the signals needed for the cancer cells to multiply and survive and may also reduce the chance of the cancer becoming resistant to treatment.
The purpose of this study is to test whether tacabrutideg is safe and if it can treat B-cell malignancies. The main goals are to ensure the drug is safe by monitoring side effects and to understand how well patients respond to the treatment and whether their cancers shrink or disappear.
This study consists of two parts: dose escalation and dose expansion. During the dose escalation part, the study doctors will test different doses of the study drug to find the recommended dose that people can take without having serious side effects. During the dose expansion part, the study doctors will test the study drug in a larger number of people using the dose or doses identified from dose escalation. The study is open label, which means that the participants and the study doctors will know what treatment is received.
This study will enroll approximately 689 participants with B-cell malignancies at multiple centers worldwide.
The overall time to participate in this study is approximately 3 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor and imaging tests.
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Study Director, MD
Estude backup de contato
- Nome: BeOne Medicines
- Número de telefone: 1.877.828.5568
- E-mail: clinicaltrials@beonemed.com
Locais de estudo
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Cologne, Alemanha, 50937
- Recrutamento
- Uniklinik Koeln (Aoer)
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Dresden, Alemanha, 01307
- Recrutamento
- Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
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Leipzig, Alemanha, 04103
- Recrutamento
- Universitares Krebszentrum Leipzig
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Lübeck, Alemanha, 23538
- Recrutamento
- Universitaetsklinikum Schleswig Holstein Campus Luebeck
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Mainz, Alemanha, 55131
- Recrutamento
- Klinikum Johannes Gutenberg Universitaet Mainz
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München, Alemanha, 81377
- Recrutamento
- Klinikum Grosshadern Ludwig Maximilians Universitat Munchen
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Ulm, Alemanha, 89081
- Recrutamento
- Universitaetsklinikum Ulm
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New South Wales
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Concord, New South Wales, Austrália, NSW 2139
- Recrutamento
- Concord Repatriation General Hospital
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Waratah, New South Wales, Austrália, NSW 2298
- Recrutamento
- Calvary Mater Newcastle
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Queensland
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Woolloongabba, Queensland, Austrália, QLD 4102
- Recrutamento
- Princess Alexandra Hospital
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Victoria
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Fitzroy, Victoria, Austrália, VIC 3065
- Recrutamento
- St Vincents Hospital Melbourne
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Heidelberg, Victoria, Austrália, VIC 3084
- Recrutamento
- Austin Health
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Melbourne, Victoria, Austrália, VIC 3004
- Recrutamento
- The Alfred Hospital
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Melbourne, Victoria, Austrália, VIC 3000
- Recrutamento
- Peter Maccallum Cancer Centre
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Western Australia
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Nedlands, Western Australia, Austrália, WA 6009
- Recrutamento
- Linear Clinical Research
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West Perth, Western Australia, Austrália, WA 6005
- Recrutamento
- Perth Blood Institute
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Brasília, Brasil, 70200-730
- Recrutamento
- Hospital Sirio Libanes Brasilia
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Curitiba, Brasil, 81520-060
- Recrutamento
- Hospital Erasto Gaertner
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Porto Alegre, Brasil, 90110-270
- Recrutamento
- Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
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São Paulo, Brasil, 05652-900
- Recrutamento
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brasil, 01321-001
- Recrutamento
- Real E Benemerita Associacao Portuguesa de Sao Paulo
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São Paulo, Brasil, 01409-001
- Recrutamento
- Hospital Nove de Julho Dasa
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São Paulo, Brasil, 01401-004
- Recrutamento
- Instituto Dor de Pesquisa E Ensino Sao Paulo
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Alberta
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Calgary, Alberta, Canadá, T2N 5G2
- Recrutamento
- Arthur Je Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canadá, T6G 1Z2
- Recrutamento
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 4E6
- Recrutamento
- British Columbia Cancer Agency the Vancouver Centre
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Ontario
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Toronto, Ontario, Canadá, M5G 2M9
- Recrutamento
- Princess Margaret Cancer Centre
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Quebec
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Québec, Quebec, Canadá, G1J 1Z4
- Recrutamento
- Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100730
- Ativo, não recrutando
- Peking Union Medical College Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Ativo, não recrutando
- Nanfang Hospital, Southern Medical University
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Henan
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Zhengzhou, Henan, China, 450000
- Ativo, não recrutando
- Henan Cancer Hospital
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Hubei
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Yichang, Hubei, China, 443001
- Ativo, não recrutando
- Yichang Central Peoples Hospitaljiangnan Branch
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200025
- Ativo, não recrutando
- Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 301617
- Ativo, não recrutando
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
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Zhejiang
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Wenzhou, Zhejiang, China, 325000
- Ativo, não recrutando
- The First Affiliated Hospital of Wenzhou Medical University
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Busan Gwang'Yeogsi
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Seogu, Busan Gwang'Yeogsi, Coréia do Sul, 49241
- Recrutamento
- Pusan National University Hospital
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Seoul Teugbyeolsi
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GangnamGu, Seoul Teugbyeolsi, Coréia do Sul, 06351
- Recrutamento
- Samsung Medical Center
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SeochoGu, Seoul Teugbyeolsi, Coréia do Sul, 06591
- Recrutamento
- The Catholic University of Korea, Seoul St Marys Hospital
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SeodaemunGu, Seoul Teugbyeolsi, Coréia do Sul, 03722
- Recrutamento
- Severance Hospital Yonsei University Health System
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Seoul, Seoul Teugbyeolsi, Coréia do Sul, 03080
- Recrutamento
- Seoul National University Hospital
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SongpaGu, Seoul Teugbyeolsi, Coréia do Sul, 05505
- Recrutamento
- Asan Medical Center
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Barcelona, Espanha, 08035
- Recrutamento
- Hospital Universitario Vall Dhebron
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Madrid, Espanha, 28046
- Recrutamento
- Hospital Universitario La Paz
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Madrid, Espanha, 28033
- Recrutamento
- Md Anderson Cancer Center Madrid Spain
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Madrid, Espanha, 28007
- Recrutamento
- Hospital General Universitario Gregorio Maranon
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Madrid, Espanha, 28040
- Recrutamento
- Hospital Universitario Fundacion Jimenez Diaz
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Majadahonda, Espanha, 28222
- Recrutamento
- Hospital Universitario Puerta de Hierro Majadahonda
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Valencia, Espanha, 46010
- Recrutamento
- Hospital Clinico Universitario de Valencia
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-0004
- Recrutamento
- University of Alabama At Birmingham Hospital
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Arizona
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Phoenix, Arizona, Estados Unidos, 85054-4502
- Concluído
- Mayo Clinic Phoenix
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Scottsdale, Arizona, Estados Unidos, 85258-4566
- Recrutamento
- Honor Health Research Institute
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Tucson, Arizona, Estados Unidos, 85724-0001
- Recrutamento
- University of Arizona Cancer Center
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California
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La Jolla, California, Estados Unidos, 92093-1503
- Recrutamento
- University of California San Diego (Ucsd) Moores Cancer Center
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Palo Alto, California, Estados Unidos, 94304-2205
- Recrutamento
- Stanford Medicine
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Santa Monica, California, Estados Unidos, 90404-2023
- Recrutamento
- UCLA Santa Monica Cancer Care
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Colorado
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Fort Collins, Colorado, Estados Unidos, 80528-3413
- Recrutamento
- Uchealth North
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Florida
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Jacksonville, Florida, Estados Unidos, 32224-1865
- Recrutamento
- Mayo Clinic Jacksonville
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Miami, Florida, Estados Unidos, 33140
- Recrutamento
- Mount Sinai Medical Center Braman Comprehensive Cancer Center
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Tampa, Florida, Estados Unidos, 33606-3571
- Recrutamento
- Tampa General Hospital Cancer Institute
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Georgia
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Augusta, Georgia, Estados Unidos, 30912-0002
- Recrutamento
- Augusta University
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Newnan, Georgia, Estados Unidos, 30265-8001
- Recrutamento
- Southeastern Regional Medical Center
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Illinois
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Zion, Illinois, Estados Unidos, 60099-2676
- Concluído
- Midwestern Regional Medical Center
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242-1009
- Recrutamento
- University of Iowa Hospitals and Clinics
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207-4700
- Ativo, não recrutando
- Norton Cancer Institute Pavilion
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809-3738
- Recrutamento
- Mary Bird Perkins Cancer Center
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Maryland
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Bethesda, Maryland, Estados Unidos, 20817-7847
- Recrutamento
- American Oncology Partners of Maryland Pa
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215-5418
- Recrutamento
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, Estados Unidos, 48201-2013
- Recrutamento
- Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905-0001
- Recrutamento
- Mayo Clinic Rochester
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89169-3321
- Recrutamento
- Comprehensive Cancer Centers of Nevada
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New York
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Buffalo, New York, Estados Unidos, 14203
- Recrutamento
- Roswell Park Comprehensive Cancer Center
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New York, New York, Estados Unidos, 10032
- Recrutamento
- Columbia University Medical Center
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New York, New York, Estados Unidos, 10065-6800
- Recrutamento
- Memorial Sloan Kettering Cancer Center Mskcc
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New York, New York, Estados Unidos, 10065-4870
- Recrutamento
- Weill Cornell Medical College Newyork Presbyterian Hospital
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37404
- Recrutamento
- Tennesse Oncology Chattanooga Downtown
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Nashville, Tennessee, Estados Unidos, 37203
- Recrutamento
- Tennessee Oncology, Pllc Nashville
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Texas
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Houston, Texas, Estados Unidos, 77030-3907
- Recrutamento
- Md Anderson Cancer Center
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Recrutamento
- Virginia Commonwealth University Massey Cancer Center
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Washington
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Seattle, Washington, Estados Unidos, 98109-4433
- Recrutamento
- Fred Hutchinson Cancer Research Center
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Bordeaux, França, 33076
- Recrutamento
- Centre de Lutte Contre Le Cancer Institut Bergonie
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ClermontFerrand, França, 63100
- Recrutamento
- Hopital Estaing
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Créteil, França, 94000
- Recrutamento
- Chu Henri Mondor
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Lille, França, 59000
- Recrutamento
- Hopital Claude Huriez Chu Lille
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Lyon, França, 69373
- Recrutamento
- Centre Leon Berard
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Marseille, França, 13009
- Recrutamento
- Institut Paoli Calmettes
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Montpellier, França, 34090
- Recrutamento
- Chu Montpellier Hopital Saint Eloi
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Paris, França, 75013
- Recrutamento
- Hopital de La Pitie Salpetriere
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Rouen, França, 76038
- Recrutamento
- Centre Henri Becquerel
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Tbilisi, Geórgia, 0119
- Recrutamento
- Arensia Exploratory Medicine Llc
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Bologna, Itália, 40138
- Recrutamento
- Policlinico Sorsola Malpighi, Aou Di Bologna
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Milan, Itália, 20132
- Recrutamento
- Ospedale San Raffaele
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Milan, Itália, 20162
- Recrutamento
- Niguarda Cancer Center Division of Hematology
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Milan, Itália, 20141
- Recrutamento
- Istituto Europeo Di Oncologia
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Roma, Itália, 00168
- Recrutamento
- Fondazione Policlinico Universitario Agostino Gemelli
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Verona, Itália, 37134
- Recrutamento
- Centroricerche Cliniche Di Verona Srl
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Yokohama, Japão, 221-0855
- Recrutamento
- Yokohama Municipal Citizens Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japão, 464-8681
- Recrutamento
- Aichi Cancer Center Hospital Clinical Oncology
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Chiba
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Chiba, Chiba, Japão, 260-8717
- Recrutamento
- Chiba Cancer Center
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Kashiwa, Chiba, Japão, 277-8577
- Recrutamento
- National Cancer Center Hospital East
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Tokyo
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Kotoku, Tokyo, Japão, 135-8550
- Recrutamento
- Cancer Institute Hospital of Jfcr
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Chisinau, Moldávia, 2025
- Recrutamento
- The Institute of Oncology, Arensia Exploratory Medicine
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Edinburgh, Reino Unido, EH4 2XU
- Recrutamento
- Edinburgh Cancer Centre
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Leeds, Reino Unido, LS9 7TF
- Recrutamento
- St Jamess University Hospital
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Newcastle upon Tyne, Reino Unido, NE7 7DN
- Recrutamento
- Freeman Hospital
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Newmarket, Reino Unido, CB8 7XN
- Recrutamento
- Genesiscare Cambridge
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Norwich, Reino Unido, NR4 7UY
- Recrutamento
- Norfolk and Norwich University Hospitals Nhs Foundation Trust
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Nottingham, Reino Unido, NG5 1PB
- Recrutamento
- Nottingham University Hospitals Nhs Trust
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Plymouth, Reino Unido, PL6 8DH
- Recrutamento
- Derriford Hospital
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Gothenburg, Suécia, 413 46
- Recrutamento
- Sahlgrenska University Hospital Hematology
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Stockholm, Suécia, 171 76
- Recrutamento
- Karolinska Universitetssjukhuset Solna
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Balçova, Turquia (Türkiye), 35330
- Recrutamento
- Dokuz Eylul University
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Kayseri, Turquia (Türkiye), 38030
- Recrutamento
- Erciyes University
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Sakarya, Turquia (Türkiye), 54100
- Recrutamento
- Sakarya Training and Research Hospital
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Samsun, Turquia (Türkiye), 55200
- Recrutamento
- Ondokuz Mayis University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria :
- Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.
- Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
- For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
- Measurable disease by radiographic assessment or serum IgM level (WM only)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).
Exclusion Criteria:
- Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
- Requires ongoing systemic treatment for any other malignancy
- Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
- Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
- Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Part 1a (Monotherapy Dose Escalation)
Dose escalation in specific subtypes of non-Hodgkin lymphoma (NHL), including relapsed or refractory (R/R) marginal zone lymphoma (MZL), R/R follicular lymphoma (FL) Grades 1, 2, and 3a, R/R mantle cell lymphoma (MCL), R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), R/R diffuse large B-cell lymphoma (DLBCL), R/R Richter's transformation (RT), and R/R Waldenström macroglobulinemia (WM), to evaluate the safety and tolerability of tacabrutideg. |
Orally administered
Outros nomes:
|
|
Experimental: Part 1b (Monotherapy Safety Expansion)
Participants with R/R MZL, MCL, CLL/SLL, and WM will be enrolled at selected doses to help determine the recommended dose(s) for expansion (RDFE(s)) for tacabrutideg. |
Orally administered
Outros nomes:
|
|
Experimental: Part 1c (Additional Monotherapy Safety Expansion)
Additional safety data will be collected from participants with R/R MZL, WM, RT, DLBCL, or FL to confirm the RDFE(s) of tacabrutideg for those with non-CLL/SLL/MCL histologies. |
Orally administered
Outros nomes:
|
|
Experimental: Part 1d (Additional Monotherapy Safety Expansion in R/R CLL/SLL)
Participants with R/R CLL/SLL will be enrolled at selected RDFE(s) to generate additional safety and efficacy data for tacabrutideg. |
Orally administered
Outros nomes:
|
|
Experimental: Part 1e (Japan-only Cohort)
Japanese participants with R/R MZL, FL, MCL, CLL/SLL, and WM will be enrolled at selected RDFE(s) to assess the safety and tolerability of tacabrutideg. |
Orally administered
Outros nomes:
|
|
Experimental: Part 1f (Additional Monotherapy Safety Expansion in BTKi Naive B-Cell Malignancies)
Participants with CLL/SLL, MCL, WM, MZL, or Richter's transformation to DLBCL who have not received a prior BTKi (either covalent or noncovalent) will be enrolled at selected dose levels. |
Orally administered
Outros nomes:
|
|
Experimental: Phase 2 (Monotherapy Expansion)
Cohorts of participants with R/R CLL/SLL, R/R MCL, R/R WM, R/R MZL, R/R FL, R/R RT, and R/R DLBCL will be enrolled to receive the RDFE(s) identified in Phase 1 to further evaluate the safety and efficacy of tacabrutideg. |
Orally administered
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Phase 1: Number of Participants with Adverse Events (AEs)
Prazo: From the first dose of tacabrutideg until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks)
|
Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) including results from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicities (DLTs); as graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. |
From the first dose of tacabrutideg until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (Up to 47 weeks)
|
|
Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Tacabrutideg
Prazo: Approximately 28 days
|
MTD is defined as the highest evaluated dose with an estimated toxicity rate closest to the target, while MAD is the highest dose given if MTD is not reached. |
Approximately 28 days
|
|
Phase 1: Recommended dose(s) for Expansion (RDFE) of tacabrutideg
Prazo: Approximately 3 years
|
RDFE of tacabrutideg alone will be determined based upon the MTD or MAD. |
Approximately 3 years
|
|
Phase 2: Overall response rate (ORR)
Prazo: approximately 3 years
|
Defined as the percentage of participants achieving a best overall response of partial response (PR) or better, assessed by the Independent Review Committee for participants with R/R CLL/SLL and R/R WM (in participants with WM, this is also referred to as major response rate) and by the investigator for other cohorts (R/R MCL, R/R MZL, R/R FL, R/R non-GCB DLBCL, R/R Richter's transformation to DLBCL), evaluated using the Lugano criteria for NHL and SLL, International Workshop of Chronic Lymphocytic Leukemia (iwCLL) criteria for CLL, and the 11th International Workshop on Waldenstrom's Macroglobulinemia (IWWM-11) criteria for WM. |
approximately 3 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Single dose and steady-state maximum observed plasma concentration (Cmax) of tacabrutideg
Prazo: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
|
|
Single dose and steady-state minimum observed plasma concentration (Cmin) of tacabrutideg
Prazo: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
|
|
Single dose and steady-state time to reach Cmax (tmax) of tacabrutideg
Prazo: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Single dose and steady-state elimination half-life (T1/2) of tacabrutideg
Prazo: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Single dose and steady-state area under the plasma concentration-time curve (AUC) of tacabrutideg
Prazo: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Single dose and steady-state apparent total clearance of drug from plasma after oral administration (CL/F) of tacabrutideg
Prazo: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Single dose and steady-state apparent volume of distribution (Vz/F) of tacabrutideg
Prazo: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Single dose and steady-state accumulation ratios of tacabrutideg
Prazo: Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 2, 4, 6, 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose; and 2, 4, 6, 8 post-dose; Week 9 Day 1 pre-dose.
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Bruton's tyrosine kinase (BTK) protein degradation in peripheral blood after tacabrutideg monotherapy
Prazo: Week 1 Day 1 pre-dose; 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose and 8 hours post-dose; Week 9 Day 1 pre-dose.
|
Week 1 Day 1 pre-dose; 8, 24, 48, and 72 hours post-dose; Week 5 Day 1 pre-dose and 8 hours post-dose; Week 9 Day 1 pre-dose.
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Phase 1: Overall response rate (ORR)
Prazo: approximately 3 years
|
Defined as the percentage of participants whose best overall response is partial response or better, as assessed by the investigator and evaluated according to the following criteria: the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for R/R CLL, the International Workshop on Waldenström's Macroglobulinemia (IWWM-11) criteria for R/R WM (in participants with WM, this is also referred to as major response rate), and the Lugano criteria for R/R NHL. |
approximately 3 years
|
|
Phase 1: Response Rate in Participants with R/R CLL/SLL
Prazo: approximately 3 years
|
Defined as the percentage of participants with R/R CLL/SLL whose best overall response is better than stable disease, as determined by investigators. |
approximately 3 years
|
|
Phase 1: Overall Response Rate in Participants with R/R WM
Prazo: approximately 3 years
|
Defined as the percentage of participants with R/R WM who have a response rate of minor response or better. |
approximately 3 years
|
|
Phase 1: Number of Participants with AEs in part 1e (Japan-only cohort)
Prazo: From the first dose of tacabrutideg in Part 1e until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
|
Number of Japanese participants in Part 1e with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, that meet protocol-defined DLTs, graded according to the NCI-CTCAE v5.0. |
From the first dose of tacabrutideg in Part 1e until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
|
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Phase 2: Recommended Phase 2 Dose (RP2D)
Prazo: approximately 3 years
|
The Recommended Phase 2 Dose (RP2D) is determined by the sponsor based on the Safety Monitoring Committee's recommendations, taking into account the overall clinical safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data. |
approximately 3 years
|
|
Phase 2: Number of Participants with AEs
Prazo: From the first dose of tacabrutideg in Phase 2 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
|
Number of participants with TEAEs and SAEs, including results from laboratory assessments, ECGs, and physical examinations, graded according to the NCI-CTCAE v5.0. |
From the first dose of tacabrutideg in Phase 2 until 30 days after the last dose of the study drug or before the initiation of a new anticancer therapy, whichever occurs first (approximately 3 years)
|
|
Phase 2: ORR in Participants with CLL/SLL assessed by investigators
Prazo: approximately 3 years
|
Defined as the percentage of participants with CLL/SLL with a best overall response of PR or better, as determined by investigators. |
approximately 3 years
|
|
Phase 2: Major Response Rate for Participants with WM assessed by investigator
Prazo: approximately 3 years
|
Defined as the percentage of participants with WM whose best overall response is PR or better, as determined by investigators using the IWWM-11 criteria. |
approximately 3 years
|
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Phase 2: Overall Response Rate for Participants with WM assessed by investigator and IRC
Prazo: approximately 3 years
|
Defined as the percentage of participants who achieve at least a minor response (MR) or a more favorable outcome, as assessed by investigators for participants with R/R WM. |
approximately 3 years
|
|
Phase 2: Rate of Very Good Partial Response (VGPR) or Better in Participants with WM Assessed by Investigator and IRC
Prazo: approximately 3 years
|
Defined as the percentage of participants with R/R WM with best response of VGPR or better as determined by IRC and investigator. |
approximately 3 years
|
|
Phase 2: Response Rate in Participants with R/R CLL/SLL Assessed by Investigator and IRC
Prazo: approximately 3 years
|
Defined as the percentage of participants with R/R CLL/SLL whose best overall response is better than stable disease, as determined by IRC and investigator. |
approximately 3 years
|
|
Phase 2: Duration of Response (DOR)
Prazo: approximately 3 years
|
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is documented or death, whichever comes first as assessed by the investigator and the IRC. |
approximately 3 years
|
|
Phase 2: Time to Overall Response (TTOR)
Prazo: approximately 3 years
|
TTOR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by IRC and the investigator |
approximately 3 years
|
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Phase 2: Time to Major Response (TTMR) in Participants with WM
Prazo: approximately 3 years
|
Defined as the time from the date of treatment initiation to the date of first response of PR or better in participants with R/R WM. |
approximately 3 years
|
|
Phase 2: Time to Response in Participants with R/R CLL/SLL Assessed by Investigator and IRC
Prazo: approximately 3 years
|
Defined as the time to first response based on best overall response of better than stable disease, per IRC and investigator. |
approximately 3 years
|
|
Phase 2: Time to Response in Participants with WM Assessed by Investigator and IRC
Prazo: approximately 3 years
|
Defined as the time to first response based on best overall response of minor response or better, per IRC and investigator. |
approximately 3 years
|
|
Phase 2: Time to Next Treatment (TTNT)
Prazo: approximately 3 years
|
Defined as the time from the treatment start date to the initiation of subsequent anticancer therapy. |
approximately 3 years
|
|
Phase 2: Progression- Free Survival (PFS)
Prazo: approximately 3 years
|
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by IRC for R/R CLL/SLL and R/R WM and by the investigator for all participants. |
approximately 3 years
|
|
Phase 2: Overall Survival (OS)
Prazo: approximately 3 years
|
OS is defined as the time from first study drug administration to the date of death due to any cause |
approximately 3 years
|
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Phase 2: Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire
Prazo: Baseline and day 1 of Weeks 5, 13, 25, and 37
|
Mean change from baseline in the 'physical well-being' and 'functional well-being' subscales of the FACT-Leu for participants with R/R CLL/SLL. FACT-Leu is a 44-item PRO questionnaire with five subscales used to measure health-related quality of life (HRQoL) in leukemia patients. |
Baseline and day 1 of Weeks 5, 13, 25, and 37
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Phase 2: National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 (NFLymSI-18)
Prazo: Baseline and day 1 of Weeks 5, 13, 25, and 37
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Mean change from baseline in the NFlymSI-18 subscales of disease-related symptoms (DRSP) and 'treatment side effects' for participants with R/R MCL and participants with R/R WM. The NFlymSI-18 is an 18-item patient-reported outcome (PRO) tool specifically designed to assess symptoms and treatment impacts in patients with non-Hodgkin lymphoma. |
Baseline and day 1 of Weeks 5, 13, 25, and 37
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Study Director, BeOne Medicines
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Neoplasias
- Doença crônica
- Atributos da doença
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Doenças Hematológicas
- Doenças Linfáticas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Leucemia de Células B
- Linfoma de Células B
- Linfoma
- Neoplasias de Células Plasmáticas
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Distúrbios hemorrágicos
- Leucemia Linfóide
- Leucemia
- Condições Patológicas, Sinais e Sintomas
- Doenças hemic e linfáticas
- Linfoma de Células B Grandes Difuso
- Leucemia Linfocítica Crônica de Células B
- Linfoma Não-Hodgkin
- Linfoma Folicular
- Linfoma de Células do Manto
- Waldenstrom Macroglobulinemia
- Linfoma de Células B, Zona Marginal
Outros números de identificação do estudo
- BGB-16673-101
- 2022-502157-33-00 (Outro identificador: EU CT Number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
See plan description
Critérios de acesso de compartilhamento IPD
See plan description
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
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