Status:
TERMINATED
Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
The primary objective of the study is to evaluate the safety and tolerability in patients with NHL and identify a maximum tolerated dose (MTD) and/or recommended dose (RD) of VAY736 single agent and i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04903197
Start Date
January 24 2022
End Date
February 24 2025
Last Update
April 2 2025
Active Locations (10)
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1
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
2
Novartis Investigative Site
Shanghai, China, 200032
3
Novartis Investigative Site
Tianjin, China, 300020
4
Novartis Investigative Site
Leipzig, Germany, 04103