Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms
NCT ID: NCT03493451
Last Updated: 2024-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2018-04-13
2021-04-21
Brief Summary
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* Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type)
* Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL)
* Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS)
Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1: ENKTL
Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Tislelizumab
Administered intravenously
Cohort 2: PTCL-NOS, AITL, and ALCL
Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Tislelizumab
Administered intravenously
Cohort 3: MF and SS
Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Tislelizumab
Administered intravenously
Interventions
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Tislelizumab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Relapsed or refractory to at least 1 prior systemic therapy
* Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) for participants in Cohort 1 and 2
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy ≥ 6 months
* Adequate respiratory function
* Adequate bone marrow function
* Adequate renal and hepatic function
Exclusion Criteria
* Previously received immune checkpoint therapy
* Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 or lower prostate cancer
* Active autoimmune disease or history of autoimmune diseases that may relapse with some exceptions
* Severe or debilitating pulmonary disease
* Clinically significant cardiovascular disease
* Active fungal, bacterial, and/or viral infection requiring systemic therapy
* Known infection with HIV or active viral hepatitis B or C infection
* Major surgery within 4 weeks of the first dose of study drug
* Pregnant or lactating women
* Vaccination with a live vaccine within 35 days prior to the first dose of study drug
* Hypersensitivity to tislelizumab
* Concurrent participation in another therapeutic clinical trial
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada
Peking University Third Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Institut Dhematologie de Basse Normandie Chu Caen Normandie
Caen, , France
Chu Hopital Lyon Sud
PierreBenite, , France
Asst Papa Giovanni Xxiii, Medicina Trasfusionale Ed Ematologia
Bergamo, , Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, , Italy
Ospedale Policlinico San Martino Irccs Per L Oncologia, Divisione Ematologia Centro Trapianti Di Mid
Genova, , Italy
Ospedale San Raffaele
Milan, , Italy
Ospedale Maggiore, Ematologia E Centro Trapianti Midollo Osseo (Ctmo), Aou Parma
Parma, , Italy
Aou Pisana, Stabilimento Di Santa Chiara
Pisa, , Italy
Azienda Ospedaliera S Maria Di Terni
Terni, , Italy
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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Huiqiang Huang, et al. Tislelizumab (BGB-A317) for relapsed/refractory extranodal NK/T-cell lymphoma: preliminary efficacy and safety results from a phase 2 study. Poster Abstract EP1268, European Hematology Association 2020.
Pier Luigi Zinzani, et al. Tislelizumab (BGB-A317) for relapsed/refractory peripheral T-cell lymphomas: Safety and efficacy results from a phase 2 study. Poster Abstract EP1235, European Hematology Association 2020.
Bachy E, Savage KJ, Huang H, Kwong YL, Gritti G, Zhang Q, Liberati AM, Cao J, Yang H, Hao S, Hu J, Zhou K, Petrini M, Russo F, Zhang H, Sang W, Ji J, Ferreri AJM, Damaj GL, Liu H, Zhang W, Ke X, Ghiggi C, Huang S, Li X, Yao H, Paik J, Novotny W, Zhou W, Zhu H, Zinzani PL. Treating relapsed/refractory mature T- and NK-cell neoplasms with tislelizumab: a multicenter open-label phase 2 study. Blood Adv. 2023 Aug 22;7(16):4435-4447. doi: 10.1182/bloodadvances.2022009575.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003700-44
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTR20171387
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-A317-207
Identifier Type: -
Identifier Source: org_study_id
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