Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Phase 2

Completed

• Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type; Angioimmunoblastic T-Cell Lymphoma Recurrent; Angioimmunoblastic T-Cell Lymphoma Refractory; Peripheral T-Cell Lymphoma Refractory; Anaplastic Large Cell Lymphoma, ALK-Positive; Anaplastic Large Cell Lymphoma, ALK-negative; Peripheral T Cell Lymphoma; Adult Nasal Type Extranodal NK/T-cell Lymphoma; PTCL; Extranodal NK/T-cell Lymphoma
• Interventions: Drug: Tislelizumab

• Registration Number: NCT03493451
• Lead Sponsor: BeiGene

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-09
• Study First Posted: 2018-04-10
• Study Start: 2018-04-13
• Primary Completion: 2021-04-21
• Study Completion: 2021-04-21
• Results First Submitted: 2022-03-25
• Results First Submitted QC: 2022-04-29
• Results First Posted: 2022-05-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 3: MF and SS	Tislelizumab	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)
Cohort 1: ENKTL	Tislelizumab	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)
Cohort 2: PTCL-NOS, AITL, and ALCL	Tislelizumab	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)

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Up to approximately 3 years and 1 week	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Up to approximately 3 years and 1 week	PFS is defined as the time from first study drug administration to the date of disease progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
Overall Survival (OS)	Up to approximately 3 years and 1 week	OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score	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)	Mean change from baseline at safety follow-up visit in EQ-5D-5L visual analogue score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' An increasing score indicates improvements from baseline.
Number of Participants With Adverse Events	Up to approximately 3 years and 1 week	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically relevant changes in laboratory tests, physical examination, electrocardiogram, and vital signs
Time to Response (TTR)	Up to approximately 3 years and 1 week	Time to response defined as the time from first study drug administration to the time the response criteria (complete response or partial response) are first met as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
Duration of Response (DOR)	Up to approximately 3 years and 1 week	DOR defined as the time from the first determination of an objective response until progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
Complete Response Rate (CRR)	Up to approximately 3 years and 1 week	CRR is defined as the percentage of participants who achieve complete response or complete metabolic response as best overall response as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score	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)	Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score	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)	Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Fatigue score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes questions related to fatigue symptoms in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status.

Trial Locations

Locations (24)

British Columbia Cancer Agency the Vancouver Centre; 🇨🇦 Vancouver, British Columbia, Canada

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, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China

Institut Dhematologie de Basse Normandie Chu Caen Normandie; 🇫🇷 Caen cedex, 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 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

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Ospedale San Raffaele; 🇮🇹 Milano, Italy

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan