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Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma

NCT04903197

TerminatedPhase 1

Sponsor: Novartis Pharmaceuticals

Conditions: Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma

Interventions: VAY736, lenalidomide

Countries: Australia, China, Germany, Italy, Japan, Singapore, South Korea

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of VAY736 alone or in combination with other therapies in patients with NHL in a platform trial.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult patients with confirmed diagnosis of relapsed/refractory B-cell NHL with all subtypes of DLBCL, follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) per WHO 2016 criteria. Patients in subtype arm e.g. DLBCL must have confirmed diagnosis of relapsed/refractory DLBCL.
* Received and failed or be intolerant to standard of care therapy (at least two prior lines, including an anti-CD20 therapy for NHL)
* Must have measurable disease and ECOG of 0 to 2

Exclusion Criteria:

* Baseline laboratory results outside of protocol defined ranges
* Patients with primary CNS lymphoma
* History of hypersensitivity to VAY736 or any drugs in similar chemical classes (e.g. monoclonal antibodies)
* Impaired cardiac function or clinically significant cardiac disease
* History of or current interstitial lung disease or pneumonitis grade 2 or higher
* 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

Other Inclusion/Exclusion criteria may apply

Locations (10)

Melbourne, Victoria, Australia
Shanghai, China
Tianjin, China
Leipzig, Germany
Brescia, BS, Italy
Rozzano, MI, Italy
Yamagata, Yamagata, Japan
Singapore, Singapore
Seoul, South Korea
Seoul, South Korea