Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms
A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK-cell Neoplasms
3 other identifiers
interventional
77
5 countries
24
Brief Summary
This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts:
- 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2018
Typical duration for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2018
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedStudy Start
First participant enrolled
April 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2021
CompletedResults Posted
Study results publicly available
May 4, 2022
CompletedOctober 26, 2024
October 1, 2024
3 years
April 4, 2018
March 25, 2022
October 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants achieving a best overall response of complete response or partial response as determined by the investigator using Lugano criteria with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification for cohorts 1 and 2 and International Society for Cutaneous Lymphomas/European Organization of Research and Treatment of Cancer (ISCL/EORTC) guidelines for cohort 3.
Up to approximately 3 years and 1 week
Secondary Outcomes (9)
Duration of Response (DOR)
Up to approximately 3 years and 1 week
Progression-free Survival (PFS)
Up to approximately 3 years and 1 week
Overall Survival (OS)
Up to approximately 3 years and 1 week
Complete Response Rate (CRR)
Up to approximately 3 years and 1 week
Time to Response (TTR)
Up to approximately 3 years and 1 week
- +4 more secondary outcomes
Study Arms (3)
Cohort 1: ENKTL
EXPERIMENTALParticipants 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)
Cohort 2: PTCL-NOS, AITL, and ALCL
EXPERIMENTALParticipants 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)
Cohort 3: MF and SS
EXPERIMENTALParticipants 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)
Interventions
Administered intravenously
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of relapsed or refractory extranodal NK/T-cell lymphoma (nasal or non-nasal type, peripheral T-cell lymphoma - not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, mycosis fungoides, or Sezary syndrome)
- 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
You may not qualify if:
- Known central nervous system (CNS) involvement by lymphoma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (24)
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Institut Dhematologie de Basse Normandie Chu Caen Normandie
Caen, 14033, France
Chu Hopital Lyon Sud
PierreBenite, 69495, France
Asst Papa Giovanni Xxiii, Medicina Trasfusionale Ed Ematologia
Bergamo, 24127, Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138, Italy
Ospedale Policlinico San Martino Irccs Per L Oncologia, Divisione Ematologia Centro Trapianti Di Mid
Genova, 16121, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Ospedale Maggiore, Ematologia E Centro Trapianti Midollo Osseo (Ctmo), Aou Parma
Parma, 43126, Italy
Aou Pisana, Stabilimento Di Santa Chiara
Pisa, 56126, Italy
Azienda Ospedaliera S Maria Di Terni
Terni, 05100, Italy
National Taiwan University Hospital
Taipei, 10048, Taiwan
Related Publications (3)
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.
BACKGROUNDPier 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.
BACKGROUNDBachy 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.
PMID: 37276067DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2018
First Posted
April 10, 2018
Study Start
April 13, 2018
Primary Completion
April 21, 2021
Study Completion
April 21, 2021
Last Updated
October 26, 2024
Results First Posted
May 4, 2022
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share