Non Hodgkin Lymphoma Clinical Trial

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

Summary

Study consists of two parts to explore BGB-16673 recommended dosing, a part 1 monotherapy dose finding and a part 2 (cohort expansion in two cohorts)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria :

Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL) , Follicular Lymphoma (FL), R/R Mantle Cell Lymphoma (MCL), R/R chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), Diffuse large B-cell lymphoma (DLBCL), or >2 treatments per the 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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

466

Study ID:

NCT05006716

Recruitment Status:

Recruiting

Sponsor:

BeiGene

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There are 84 Locations for this study

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University of Alabama At Birmingham Hospital
Birmingham Alabama, 35294, United States
Mayo Clinic Phoenix
Phoenix Arizona, 85254, United States
University of Arizona Cancer Center
Tucson Arizona, 85724, United States
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla California, 92037, United States
Valkyrie Clinical Trials
Los Angeles California, 90067, United States
UCLA Santa Monica Cancer Care
Santa Monica California, 90404, United States
Stanford Medicine
Stanford California, 94305, United States
Uchealth North
Fort Collins Colorado, 80528, United States
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
Tampa General Hospital Cancer Institute
Tampa Florida, 33606, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
Norton Cancer Institute Pavilion
Louisville Kentucky, 40207, United States
Mary Bird Perkins Cancer Center
Baton Rouge Louisiana, 70809, United States
American Oncology Partners of Maryland Pa
Bethesda Maryland, 20817, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Nebraska Cancer Specialists
Grand Island Nebraska, 68803, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Summit Medical Group
Florham Park New Jersey, 07932, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14203, United States
Weill Cornell Medical College Newyork Presbyterian Hospital
New York New York, 10021, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York New York, 10065, United States
Md Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Concord Repatriation General Hospital
Concord New South Wales, 2139, Australia
Princess Alexandra Hospital
Brisbane Queensland, 4102, Australia
St Vincents Hospital Melbourne
Fitzroy Victoria, 3065, Australia
Peninsula Private Hospital
Frankston Victoria, 3199, Australia
Peter Maccallum Cancer Centre
Melbourne Victoria, 3000, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Linear Clinical Research
Nedlands Western Australia, 6009, Australia
Perth Blood Institute
West Perth Western Australia, 6005, Australia
Instituto de Pesquisa Em Saude Da Universidade de Caxias Do Sul
Caxias do Sul , 95070, Brazil
Hospital Erasto Gaertner
Curitiba , 81520, Brazil
Real E Benemerita Associacao Portuguesa de Sao Paulo
Sao Paulo , 01321, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
Sao Paulo , 01401, Brazil
Hospital Nove de Julho Dasa
Sao Paulo , 01409, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Sao Paulo , 05653, Brazil
Tom Baker Cancer Center
Calgary Alberta, T2N 4, Canada
Chu de Quebec Universite Laval
Quebec , G1J 1, Canada
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux , 33076, France
Hopital Estaing
Clermont Ferrand , 63003, France
Chu Henri Mondor
Creteil , 94000, France
Hopital Claude Huriez Chu Lille
Lille , 59000, France
Institut Paoli Calmettes
Marseille , 13009, France
Chu Montpellier Hopital Saint Eloi
Montpellier Cedex , 34295, France
Hopital de La Pitie Salpetriere
Paris , 75013, France
Centre Henri Becquerel
Rouen Cedex , 76038, France
Arensia Exploratory Medicine Llc
Tbilisi , 0112, Georgia
Universitaetsklinikum Schleswig Holstein Campus Luebeck
Luebeck , 23538, Germany
Universitaetsklinikum Ulm, Innere Medizin Iii
Ulm , 89081, Germany
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna , 40138, Italy
Ospedale San Raffaele
Milano , 20132, Italy
Istituto Europeo Di Oncologia
Milano , 20141, Italy
Niguarda Cancer Center Division of Hematology
Milano , 20162, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma , 168, Italy
Centroricerche Cliniche Di Verona Srl
Verona , 37134, Italy
Inje University Busan Paik Hospital
Busan Busan Gwang'yeogsi, 47392, Korea, Republic of
Pusan National University Hospital
Busan Busan Gwang'yeogsi, 49241, Korea, Republic of
Seoul National University Hospital
Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Asan Medical Center
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Samsung Medical Center
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
The Catholic University of Korea, Seoul St Marys Hospital
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau , 2025, Moldova, Republic of
Hospital de La Santa Creu I Sant Pau
Barcelona , 08025, Spain
Hospital Universitario Vall Dhebron
Barcelona , 08035, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28007, Spain
Md Anderson Cancer Center Madrid Spain
Madrid , 28033, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , 28222, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Sahlgrenska University Hospital Hematology
Goteborg , 41345, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm , 171 7, Sweden
Uppsala Akademiska Sjukhus
Uppsala , 75185, Sweden
Churchill Hospital Oxford University Hospital Nhs Trust
Headington , OX3 7, United Kingdom
St Jamess University Hospital
Leeds , LS9 7, United Kingdom
Freeman Hospital
NewCastle Upon Tyne , NE7 7, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

466

Study ID:

NCT05006716

Recruitment Status:

Recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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