Clinical trial NCT03493451: Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms
Official title: A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK-cell Neoplasms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral T Cell Lymphoma
PTCL
Extranodal NK/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Extranodal NK T Cell Lymphoma
Extranodal NK T Cell Lymphoma, Nasal
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Angioimmunoblastic T-Cell Lymphoma Recurrent
Angioimmunoblastic T-Cell Lymphoma Refractory
Peripheral T-cell Lymphoma NOS
Peripheral T-Cell Lymphoma, Not Otherwise Specified
Peripheral T-Cell Lymphoma Refractory
Anaplastic Large Cell Lymphoma
Anaplastic Large Cell Lymphoma, ALK-Positive
Anaplastic Large Cell Lymphoma, ALK-negative
ALK-negative Anaplastic Large Cell Lymphoma
ALK-Positive Anaplastic Large Cell Lymphoma
Cutaneous T-cell Lymphoma
Keywords: T/NK-cell
NK/T-cell
extranodal
nasal
NK-cell
ENKTL
peripheral T-cell
anaplastic large cell
ALCL
angioimmunoblastic
PTCL-NOS
Relapsed
Refractory
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2018-04-10
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Key Inclusion Criteria

* 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

Key Exclusion Criteria

* 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 3 years and 1 week
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to approximately 3 years and 1 week
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 3 years and 1 week
measure: Overall Survival (OS)
timeFrame: Up to approximately 3 years and 1 week
measure: Complete Response Rate (CRR)
timeFrame: Up to approximately 3 years and 1 week
measure: Time to Response (TTR)
timeFrame: Up to approximately 3 years and 1 week
measure: Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score
timeFrame: Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)
measure: Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score
timeFrame: Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)
measure: Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score
timeFrame: Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)
measure: Number of Participants With Adverse Events
timeFrame: Up to approximately 3 years and 1 week
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency the Vancouver Centre
state: British Columbia
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Caen cedex
country: France
facility: Institut Dhematologie de Basse Normandie Chu Caen Normandie
city: PierreBenite
country: France
facility: Chu Hopital Lyon Sud
city: Bergamo
country: Italy
facility: Asst Papa Giovanni Xxiii, Medicina Trasfusionale Ed Ematologia
city: Bologna
country: Italy
facility: Policlinico Sorsola Malpighi, Aou Di Bologna
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino Irccs Per L Oncologia, Divisione Ematologia Centro Trapianti Di Mid
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Parma
country: Italy
facility: Ospedale Maggiore, Ematologia E Centro Trapianti Midollo Osseo (Ctmo), Aou Parma
city: Pisa
country: Italy
facility: Aou Pisana, Stabilimento Di Santa Chiara
city: Terni
country: Italy
facility: Azienda Ospedaliera S Maria Di Terni
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.