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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Drug: BGB A317
BGB A317 200 mg IV on Day 1 of each 21-day cycle.
Other Name: Tislelizumab
- Objective response rate (ORR) [ Time Frame: Up to 2 years ]
- Duration of response (DOR) [ Time Frame: Up to 2 years ]
- Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
- Overall survival (OS) [ Time Frame: Up to 2 years ]
- Rate of complete response [ Time Frame: Up to 2 years ]
- Time to Response (TTR) [ Time Frame: Up to 2 years ]
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
|Contact: Jason Paik, MD PhDemail@example.com|
|Contact: Ted Shih, PharmDfirstname.lastname@example.org|
Show 35 Study Locations
|Study Director:||William Novotny, MD||BeiGene|