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RecruitingLast updated: 7 February 2024

This phase I study is assessing how safe, tolerable and effective a targeted therapy (VAY736) is alone, and in combination with cancer drug lenalidomide, in people with relapsed or refractory B-cell non-Hodgkin lymphomaA Phase Ib, Multi-center, Open-label Dose Escalation and Expansion Platform Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (NHL)

Clinical summary

Summary

This trial is comprised of two cohorts that both have a dose escalation part and a dose expansion part. In Cohort 1, participants will receive VAY736 as a single agent. In Cohort 2, participants will receive VAY736 in combination with lenalidomide.

Conditions

This trial is treating patients with relapsed and refractory B-cell non-Hodgkin lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Phase Ib, Multi-center, Open-label Dose Escalation and Expansion Platform Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin Lymphoma (NHL)

Eligibility

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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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