Phase
Condition
Neoplasms
Waldenstrom Macroglobulinemia
Leukemia
Treatment
BGB-16673
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria :
Confirmed diagnosis (per World Health Organization (WHO) guidelines, unlessotherwise noted) of one of the following: Marginal Zone Lymphoma (MZL) , FollicularLymphoma (FL), R/R Mantle Cell Lymphoma (MCL), R/R chronic lymphocytic leukemia andsmall lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), Diffuselarge B-cell lymphoma (DLBCL), or >2 treatments per the Richter's transformation toDLBCL.
Participants who have previously received a covalently-binding Bruton´s tyrosinekinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatmentwith the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation isintolerance).
For dose-finding and dose-expansion, participants who had previously received acovalently-binding BTK inhibitor as monotherapy or in combination with otheranticancer agents are eligible for the study if they meet any of the followingcriteria: discontinued the previous BTK inhibitor due to disease progression,experienced disease progression after completing treatment with a BTK inhibitor ordiscontinued 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 previouslytreated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis andcountry 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/SLLparticipants, 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
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 breastcancer treated with curative intent with no evidence of breast active disease formore than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, orany other cancer treated with curative intent, not on adjuvant treatment, and in theopinion 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, spinalcord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, orbiopsy) by B-cell malignancy, regardless of whether participants had receivedtreatment for central nervous system disease
Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkittlymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma,Castleman disease, post-transplant lymphoproliferative disorders, hairy cellleukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of thecentral nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associatedwith chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma,intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusionlymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements,high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with featuresintermediate between DLBCL and classical Hodgkin lymphoma, or history of orcurrently suspected transformation of an indolent lymphoma to an aggressivehistology (except for participants with Richter Transformation to DLBCL are eligiblefor Part 1a, 1c, or Phase 2 and participants with history of follicular lymphomatransforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Concord Repatriation General Hospital
Concord, New South Wales 2139
AustraliaActive - Recruiting
Calvary Mater Newcastle
Waratah, New South Wales 2298
AustraliaActive - Recruiting
Princess Alexandra Hospital
Brisbane, Queensland 4102
AustraliaActive - Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
St. Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Peninsula Private Hospital
Frankston, Victoria 3199
AustraliaActive - Recruiting
Austin Health
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Peter MacCallum Cancer Institute
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Peter Maccallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Linear Clinical Research
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Perth Blood Institute
West Perth, Western Australia 6005
AustraliaActive - Recruiting
Hospital Sirio Libanes Brasilia
Brasilia, 70200-730
BrazilActive - Recruiting
Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul
Caxias do Sul, 95070-560
BrazilActive - Recruiting
Hospital Erasto Gaertner
Curitiba, 81520-060
BrazilActive - Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90850-170
BrazilActive - Recruiting
Hospital Ernesto Dornelles
Porto Alegre, 90160-093
BrazilActive - Recruiting
Hospital Alemao Oswaldo Cruz
Sao Paulo, 04829-310
BrazilActive - Recruiting
Hospital Nove de Julho Dasa
Sao Paulo, 01409-902
BrazilActive - Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
Sao Paulo, 01401-002
BrazilActive - Recruiting
Real E Benemerita Associacao Portuguesa de Sao Paulo
Sao Paulo, 01321-001
BrazilActive - Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Sao Paulo, 05653-120
BrazilActive - Recruiting
Hospital Santa Rita de Cassia Afecc
Vitoria, 29043260
BrazilActive - Recruiting
Tom Baker Cancer Center
Calgary, Alberta T2N 4N2
CanadaActive - Recruiting
Cross Cancer Institute
Edmonton, Alberta T6G1Z2
CanadaActive - Recruiting
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia V5Z 4E6
CanadaActive - Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2C9
CanadaActive - Recruiting
Arthur Je Child Comprehensive Cancer Centre
Calgary, T2N 5G2
CanadaActive - Recruiting
Chu de Quebec Universite Laval
Quebec, G1J 1Z4
CanadaActive - Recruiting
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Quebec, G1J 1Z4
CanadaActive - Recruiting
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33076
FranceActive - Recruiting
Hopital Estaing
Clermont Ferrand, 63003
FranceActive - Recruiting
Chu Henri Mondor
Creteil, 94000
FranceActive - Recruiting
Hopital Claude Huriez Chu Lille
Lille, 59000
FranceActive - Recruiting
Centre Leon Berard
Lyon Cedex, 69373
FranceActive - Recruiting
Institut Paoli Calmettes
Marseille, 13009
FranceActive - Recruiting
Chu Montpellier Hopital Saint Eloi
Montpellier Cedex, 34295
FranceActive - Recruiting
Hopital de La Pitie Salpetriere
Paris, 75013
FranceActive - Recruiting
Centre Henri Becquerel
Rouen Cedex, 76038
FranceActive - Recruiting
Arensia Exploratory Medicine Llc
Tbilisi, 0112
GeorgiaActive - Recruiting
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, 01307
GermanyActive - Recruiting
Uniklinik Koln (Aor)
Koln, 50937
GermanyActive - Recruiting
Universitares Krebszentrum Leipzig
Leipzig, 04103
GermanyActive - Recruiting
Universitaetsklinikum Schleswig Holstein Campus Luebeck
Luebeck, 23538
GermanyActive - Recruiting
Klinikum Johannes Gutenberg Universitaet Mainz
Mainz, 55131
GermanyActive - Recruiting
Klinikum Grosshadern Ludwig Maximilians Universitat Munchen
Munich, 81377
GermanyActive - Recruiting
Universitaetsklinikum Ulm, Innere Medizin Iii
Ulm, 89081
GermanyActive - Recruiting
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138
ItalyActive - Recruiting
Ospedale San Raffaele
Milan, 20132
ItalySite Not Available
Istituto Europeo Di Oncologia
Milano, 20141
ItalyActive - Recruiting
Niguarda Cancer Center Division of Hematology
Milano, 20162
ItalyActive - Recruiting
Ospedale San Raffaele
Milano, 20132
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
ItalyActive - Recruiting
Centroricerche Cliniche Di Verona Srl
Verona, 37134
ItalyActive - Recruiting
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi 464-8681
JapanActive - Recruiting
Chiba Cancer Center
Chibashi, Chiba 260-8717
JapanActive - Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
JapanSite Not Available
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo 135-8550
JapanActive - Recruiting
Yokohama Municipal Citizens Hospital
Yokohamashi, 221-0855
JapanActive - Recruiting
Inje University Busan Paik Hospital
Busan, Busan Gwang'yeogsi 47392
Korea, Republic ofActive - Recruiting
Pusan National University Hospital
Busan, Busan Gwang'yeogsi 49241
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, Seoul Teugbyeolsi 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, Seoul St Marys Hospital
Seoul, Seoul Teugbyeolsi 06591
Korea, Republic ofActive - Recruiting
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, 2025
Moldova, Republic ofActive - Recruiting
Hospital Universitario Vall Dhebron
Barcelona, 08035
SpainActive - Recruiting
Hospital de La Santa Creu I Sant Pau
Barcelona, 08025
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Md Anderson Cancer Center Madrid Spain
Madrid, 28033
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainActive - Recruiting
Sahlgrenska University Hospital Hematology
Goteborg, 41345
SwedenActive - Recruiting
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
SwedenActive - Recruiting
Uppsala Akademiska Sjukhus
Uppsala, 75185
SwedenActive - Recruiting
Ankara University
Ankara, 06620
TurkeyActive - Recruiting
Dr Abdurrahman Yurtaslan Research and Training Hospital
Ankara, 06200
TurkeyActive - Recruiting
Dokuz Eylul University
Izmir, 35340
TurkeyActive - Recruiting
Erciyes University
Kayseri, 38030
TurkeyActive - Recruiting
Sakarya Training and Research Hospital
Sakarya, 54100
TurkeyActive - Recruiting
Ondokuz Mayis University
Samsun, 55200
TurkeyActive - Recruiting
Edinburgh Cancer Centre
Edinburgh, EH4 2XU
United KingdomActive - Recruiting
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, OX3 7LE
United KingdomActive - Recruiting
St Jamess University Hospital
Leeds, LS9 7TF
United KingdomActive - Recruiting
Freeman Hospital
NewCastle Upon Tyne, NE7 7DN
United KingdomActive - Recruiting
Nottingham University Hospitals Nhs Trust
Nottingham, NG51PB
United KingdomActive - Recruiting
Derriford Hospital
Plymouth, PL6 8DH
United KingdomActive - Recruiting
University of Alabama At Birmingham Hospital
Birmingham, Alabama 35294
United StatesActive - Recruiting
Western Regional Medical Center, Llc
Goodyear, Arizona 85338
United StatesActive - Recruiting
Mayo Clinic (Phoenix)
Phoenix, Arizona 85004
United StatesActive - Recruiting
Mayo Clinic Phoenix
Phoenix, Arizona 85254
United StatesActive - Recruiting
Honor Health
Scottsdale, Arizona 85258
United StatesActive - Recruiting
Honor Health Research Institute
Scottsdale, Arizona 85258
United StatesActive - Recruiting
The University of Arizona Cancer Center
Tucson, Arizona 85724-5024
United StatesActive - Recruiting
University of Arizona Cancer Center
Tucson, Arizona 85724
United StatesActive - Recruiting
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California 92037
United StatesActive - Recruiting
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesSite Not Available
Valkyrie Clinical Trials, Inc.
Los Angeles, California 90067
United StatesActive - Recruiting
UCLA Santa Monica Cancer Care
Santa Monica, California 90404
United StatesActive - Recruiting
Stanford Medicine
Stanford, California 94305
United StatesActive - Recruiting
Uchealth North
Fort Collins, Colorado 80528
United StatesActive - Recruiting
Mayo Clinic (Jacksonville)
Jacksonville, Florida 32224
United StatesActive - Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United StatesActive - Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
United StatesActive - Recruiting
Tampa General Hospital Cancer Institute
Tampa, Florida 33606
United StatesActive - Recruiting
Augusta University
Augusta, Georgia 30912
United StatesActive - Recruiting
Southeastern Regional Medical Center
Newnan, Georgia 30265
United StatesActive - Recruiting
Midwestern Regional Medical Center
Zion, Illinois 60099
United StatesActive - Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
Norton Cancer Institute Pavilion
Louisville, Kentucky 40207
United StatesCompleted
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky 40207
United StatesActive - Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
United StatesActive - Recruiting
American Oncology Partners of Maryland Pa
Bethesda, Maryland 20817
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Mayo Clinic (Rochester)
Rochester, Minnesota 55905
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
Nebraska Cancer Specialists
Grand Island, Nebraska 68803
United StatesCompleted
Nebraska Cancer Specialists
Omaha, Nebraska 68130
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United StatesActive - Recruiting
Summit Medical Group
Florham Park, New Jersey 07932
United StatesActive - Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14203
United StatesActive - Recruiting
Columbia University Medical Center
New York, New York 10032
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York 10065
United StatesActive - Recruiting
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York 10021
United StatesActive - Recruiting
Weill Cornell Medicine
New York, New York 10065
United StatesActive - Recruiting
Tennesse Oncology Chattanooga
Chattanooga, Tennessee 37404
United StatesActive - Recruiting
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee 37203
United StatesActive - Recruiting
Md Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
The University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia 23298
United StatesActive - Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United StatesActive - Recruiting
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