Study of safety and preliminary efficacy of VAY736 given alone or in combination with other antineoplastic agents in patients with NH
- Conditions
- on-Hodgiking Lymphoma
- Registration Number
- JPRN-jRCT2031210238
- Lead Sponsor
- Suzuki Kazuyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 86
Adult patients with histologically confirmed diagnosis of B-cell NHL with all subtypes per WHO 2016 criteria. Patients in subtype arms e.g. diffuse large B-cell lymphoma (DLBCL) must have confirmed diagnosis of r/r DLBCL.
- Received and failed or be intolerant to standard of care therapy (at least two prior lines, including an anti-CD20 therapy, but no more than 5 prior lines) .
- Must have measurable disease and ECOG =< 2
- Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy and must be willing to undergo study required biopsies at screening and during therapy.
- Baseline laboratory results outside of protocol defined ranges.
- Presence or history of central nervous system involvement by lymphoma
- Ongoing immunosuppressive therapy for treatment of lymphoma
- History of hypersensitivity to VAY736 or any of its excipients or to drugs in similar chemical classes (e.g. mAb)
- Impaired cardiac function or clinically significant cardiac disease
- History of or current interstitial lung disease or pneumonitis >= Grade 2
- Human immunodeficiency virus (HIV) infection
- Active hepatitis C infection and/or hepatitis B infection
- Pregnant or nursing (lactating) women, women of child-bearing potential unless they are using highly effective methods of contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method