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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 ]


Information from the National Library of Medicine

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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

  Show 35 Study Locations
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