Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms
Peripheral T Cell Lymphoma, PTCL, Extranodal NK/T-cell Lymphoma
About this trial
This is an interventional treatment trial for Peripheral T Cell Lymphoma focused on measuring T/NK-cell, NK/T-cell, extranodal, nasal, NK-cell, ENKTL, peripheral T-cell, anaplastic large cell, ALCL, angioimmunoblastic, PTCL-NOS, Relapsed, Refractory
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.
Sites / Locations
- UBC - British Columbia Cancer Agency - The Vancouver Centre
- Peking University Third Hospital
- Beijing Hospital
- Peking Union Medical College Hospital
- Fujian Medical University Union Hospital
- Sun Yat-Sen University Cancer Center
- He Nan Cancer Hospital
- Affiliated Tumor Hospital of Harbin Medical University
- The First Affiliated Hospital of Soochow University
- The affiliated hospital of Xuzhou medical university
- Fudan university Shanghai Cancer Center
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- West China Hospital of Sichuan University
- Tianjin Cancer Hospital
- Zhejiang Cancer Hospital
- Institut d'hématologie de Basse Normandie
- Centre hospitalier Universitaire de Limoges
- Centre hospitalier Lyon Sud
- Universitätsmedizin Göttingen
- Universitätsklinikum Halle
- Universitätsklinikum Leipzig AöR
- Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi
- Ospedale Maggiore, AOU Parma
- Ospedale Policlinico San Martino - IRCCS per l'Oncologia
- ASST Papa Giovanni XXII
- Ospedale San Raffaele
- A.O.U. Pisana, Stabilimento di Santa Chiara
- Azienda Ospedaliera Santa Maria di Terni
- National Cheng Kung University Hospital
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cohort 1: ENKTL
Cohort 2: PTCL-NOS, AITL, and ALCL
Cohort 3: MF and SS
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)
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)
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)