A Phase II Study of Nanatinostat and Valganciclovir in People with Epstein-Barr Virus-Associated Lymphoma

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Full Title

A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies

Purpose

The purpose of this study is to see if the investigational drug nanatinostat plus the antiviral drug valganciclovir is a safe and effective treatment for people with Epstein-Barr virus (EBV)-positive lymphoma that is not responding to standard lymphoma therapy. Antiviral drugs have been shown to destroy some EBV-positive tumor cells, but these drugs don’t work unless the virus is active inside the tumor cell. 

Researchers think that combining nanatinostat (also called VRx-3996) with valganciclovir may be effective against lymphoma because nanatinostat targets EBV-positive cancer cells and makes them more sensitive to valganciclovir. Valganciclovir is an approved treatment for some types of viral infections; its use in combination with nanatinostat is considered investigational. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have EBV-positive lymphoma that has come back or continued to grow despite treatment and cannot be successfully treated with standard therapies.
  • Patients should recover from the serious side effects of previous treatments before receiving the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Erel Joffe at 646-608-3703.

Protocol

20-535

Phase

I/II

Investigator

Co-Investigators