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A Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK- Neoplasms

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ClinicalTrials.gov Identifier: NCT03493451
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:

This is a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in patients with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There will be two cohorts of patients:

  • Cohort 1: Patients with relapsed or refractory extranodal NK/T cell lymphoma (nasal or non-nasal type)
  • Cohort 2: other mature T-cell neoplasms (limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, or anaplastic large-cell lymphoma)
  • Cohort 3: cutaneous T-cell lymphoma (limited to mycosis fungoides and Sèzary syndrome)

Up to 70 patients will be enrolled into cohort 1, up to 50 patients into cohort 2, and up to 10 patients into cohort 3 for a total sample size of up to 130 patients.

The primary efficacy endpoint is overall response rate (ORR) determined by investigator assessment. Disease response for the primary endpoint for cohorts 1 and 2 will be assessed per the Lugano criteria with LYRIC modification for immunomodulatory therapy Disease response for the primary endpoint for cohort 3 will be assessed per the ISCL/EORTC guidelines for immunomodulatory therapy BGB-A317 will be administered intravenously as a 200 mg infusion every 3 weeks (Each cycle consists of 21 days). Study procedures will occur over 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 AEs and SAEs); Survival follow-up phase (duration varying by patient).


Condition or disease Intervention/treatment Phase
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 Drug: BGB A317 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK- Neoplasms
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 14, 2020


Arm Intervention/treatment
Experimental: NK/T cell lymphoma and with other mature T-cell neoplasms

In this cohort, subjects will be treated with BGB A317 200 mg IV on Day 1 of each cycle.BGB A317 will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.

  • Cohort 1: Patients with relapsed or refractory extranodal NK/T cell lymphoma (nasal or non-nasal type)
  • Cohort 2: other mature T-cell neoplasms (limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified, angioimmunoblastic T-cell lymphoma, or anaplastic large-cell lymphoma)
  • Cohort 3: cutaneous T-cell lymphoma (limited to mycosis fungoides and Sèzary syndrome)
Drug: BGB A317
BGB A317 200 mg IV on Day 1 of each 21-day cycle.
Other Name: Tislelizumab




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Duration of response (DOR) [ Time Frame: Up to 2 years ]
  2. Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
  3. Overall survival (OS) [ Time Frame: Up to 2 years ]
  4. Rate of complete response [ Time Frame: Up to 2 years ]
  5. Time to Response (TTR) [ Time Frame: Up to 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 CT/magnetic resonance imaging (MRI) for patients in Cohort 1 and 2
  • 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

  • Known 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493451


Contacts
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Contact: Jason Paik, MD PhD 781-801-1800 clinicaltrials@beigene.com
Contact: Ted Shih, PharmD 781-801-1800 clinicaltrials@beigene.com

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Locations
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United States, New York
North Shore University Hospital Recruiting
Lake Success, New York, United States, 11042
Contact: Jonathan Kolitz, MD    516-734-8920    kolitz@nshs.edu   
Principal Investigator: Steven Allen, MD         
Sub-Investigator: Jonathan Kolitz, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Margaret Kasner, MD    215-955-8874    Margaret.Kasner@Jefferson.Edu   
Principal Investigator: Pierluigi Porcu, MD         
Sub-Investigator: Margaret Kasner, MD         
United States, Wisconsin
Froedtert & Medical College of Wisconsin - Froedtert Hospital - Clinical Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Timothy Fenske, MD    414-805-4600    TFenske@mcw.edu   
Principal Investigator: Nirav Shah, MD         
Sub-Investigator: Timothy Fenske, MD         
Canada, British Columbia
UBC - British Columbia Cancer Agency - The Vancouver Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Alina Gerrie, MD    604-877-6000    AGerrie@bcccancer.bc.ca   
Principal Investigator: Kerry Savage, MD         
Sub-Investigator: Alina Gerrie, MD         
China, Beijing
Peking University Third Hospital Active, not recruiting
Beijing, Beijing, China, 100000
Beijing Hospital Active, not recruiting
Beijing, Beijing, China, 100730
Peking Union Medical College Hospital Active, not recruiting
Beijing, Beijing, China, 100730
China, Fujian
Fujian Medical University Union Hospital Active, not recruiting
Fuzhou, Fujian, China, 350001
China, Guangdong
Sun Yat-Sen University Cancer Center Active, not recruiting
Guangzhou, Guangdong, China, 510060
China, He Nan
He Nan Cancer Hospital Active, not recruiting
Zhengzhou, He Nan, China, 450008
China, Heilongjiang
Affiliated Tumor Hospital of Harbin Medical University Active, not recruiting
Harbin, Heilongjiang, China, 150000
China, Hunan
Hunan Cancer Hospital Withdrawn
Changsha, Hunan, China, 410013
China, Jiangsu
The First Affiliated Hospital of Soochow University Completed
Suzhou, Jiangsu, China, 215006
The affiliated hospital of Xuzhou medical university Active, not recruiting
Xuzhou, Jiangsu, China, 221002
China, Shanghai
Fudan university Shanghai Cancer Center Active, not recruiting
Shanghai, Shanghai, China, 200032
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Active, not recruiting
Shanghai, Shanghai, China, 200092
China, Sichuan
West China Hospital of Sichuan University Active, not recruiting
Chengdu, Sichuan, China, 610041
China, Tianjin
Tianjin Cancer Hospital Completed
Tianjin, Tianjin, China, 300060
China, Zhejiang
Zhejiang Cancer Hospital Active, not recruiting
Hangzhou, Zhejiang, China, 310022
France
Institut d'hématologie de Basse Normandie Recruiting
Caen, France, 14000
Contact: Vétronique Abonnet, Engineer    +33 (0)2 31 27 21 32    abonnet-v@chu-caen.fr   
Principal Investigator: DAMAJ Gandhi Laurent, MD         
Sub-Investigator: Véronique Abonnet, Engineer         
Centre hospitalier Universitaire de Limoges Recruiting
Limoges, France, 87000
Contact: Fabienne Auroy, Degree in biology    +33 (0)5 55 05 86 33    Fabienne.Auroy@chu-limoges.fr   
Principal Investigator: JACCARD Arnaud, MD         
Sub-Investigator: Fabienne Auroy, Degree in biology         
Centre hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69310
Contact: Virginie Tronchon, PhD    +33 (0)4 78 86 43 35    virginie.tronchon@chu-lyon.fr   
Principal Investigator: BACHY Emmanuel, MD         
Sub-Investigator: Virginie Tronchon, PhD         
Germany
Universitätsmedizin Göttingen Recruiting
Göttingen, Niedersachsen, Germany, 37075
Contact: Friedericke Braulke, PD Dr.    0049 511 3917 0577    friederike.braulke@med.uni-goettingen.de   
Principal Investigator: Gerald Wulf, Prof.         
Sub-Investigator: Friedericke Braulke, PD Dr.         
Universitätsklinikum Halle Recruiting
Halle, Sachsen-Anhalt, Germany, 06120
Contact: Müller Lutz, PD Dr.    0049 345 577 7250    lutz.mueller@uk-halle.de   
Principal Investigator: Thomas Weber, Dr.         
Sub-Investigator: Müller Lutz, PD Dr.         
Universitätsklinikum Leipzig AöR Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Vladan Vucinic, Dr.    0049 341 971 3847    vladan.vucinic@medizin.uni-leipzig.de   
Principal Investigator: Dietger Niederwieser, Prof         
Sub-Investigator: Vladan Vucinic, Dr.         
Hong Kong
Queen Mary Hospital Completed
Hong Kong, Hong Kong, 00000
Italy
Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi Recruiting
Bologna, Emilia, Italy, 40138
Contact: Vittorio Stefoni, MD    0039 0516363680    vittorio.stefoni2@unibo.it   
Principal Investigator: Pier Luigi Zinzani, MD         
Sub-Investigator: Vittorio Stefoni, MD         
Ospedale Maggiore, AOU Parma Recruiting
Parma, Emilia, Italy, 43100
Contact: Filomena Russo, MD    0039 0521703962    milenarusso4@gmail.com   
Principal Investigator: Francesca Re, MD         
Sub-Investigator: Filomena Russo, MD         
Ospedale Policlinico San Martino - IRCCS per l'Oncologia Recruiting
Genova, Liguria, Italy, 16132
Contact: Emanuele Angelucci, MD    0039 0105553651    emanuele.angelucci@hsanmartino.it   
Principal Investigator: Anna Ghiso, MD         
Sub-Investigator: Emanuele Angelucci, MD         
ASST Papa Giovanni XXII Recruiting
Bergamo, Lombardia, Italy, 24127
Contact: Giuseppe Gritti, MD    0039 035269492    g.gritti@asst-pg23.it   
Principal Investigator: Alessandro Rambaldi, MD         
Sub-Investigator: Giuseppe Gritti, MD         
Ospedale San Raffaele Recruiting
Milano, Lombardia, Italy, 20123
Contact: Salvatore Perrone, MD    0039 0226435603    perrone.salvatore@hsr.it   
Principal Investigator: Andres Ferreri, MD         
Sub-Investigator: Salvatore Perrone, MD         
A.O.U. Pisana, Stabilimento di Santa Chiara Recruiting
Pisa, Toscana, Italy, 56126
Contact: Matteo Pelosini, MD    0039 050992652    mpelo78@hotmail.com   
Principal Investigator: Mario Petrini, MD         
Sub-Investigator: Matteo Pelosini, MD         
Azienda Ospedaliera Santa Maria di Terni Recruiting
Terni, Umbria, Italy, 05100
Contact: Angelo Genua, MD    00390744205971    angelogenua@tin.it   
Principal Investigator: Anna Marina Liberati, MD         
Sub-Investigator: Angelo Genua, MD         
Taiwan
National Cheng Kung University Hospital Completed
Tainan, Taiwan, 70403
National Taiwan University Hospital Active, not recruiting
Taipei, Taiwan, 10002
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: William Novotny, MD BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03493451     History of Changes
Other Study ID Numbers: BGB-A317-207
2017-003700-44 ( EudraCT Number )
CTR20171387 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
T/NK-cell
NK/T-cell
extranodal
nasal
NK-cell
ENKTL
peripheral T-cell
anaplastic large cell
ALCL
angioimmunoblastic
PTCL-NOS
Relapsed
Refractory
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Lymphoma, Extranodal NK-T-Cell
Immunoblastic Lymphadenopathy
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphadenopathy