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RecruitingLast updated: 15 February 2024

NAVAL-1: This study is evaluating the effectiveness of a combination treatment in people with relapsed or refractory Epstein-Barr Virus-Positive (EBV+) lymphomasAn Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

Clinical summary

Summary

People with Epstein-Barr Virus (EBV) associated lymphomas have inferior outcomes with standard of care therapies compared to those eith EBV-negative disease. This study is evaluating the efficacy of nanatinostat in combination with valganciclovir in people with relapsed/refractory EBV-positive lymphomas. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form.

The study will include the following cohorts if people with EBV+ relapsed/refractory lymphomas:

  • EBV+ diffuse large B-cell lymphoma (DLBCL, NOS)
  • Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL
  • Post-transplant lymphoproliferative disorder (PTLD)
  • EBV+ lymphoproliferative disorders other than the above, including Extranodal NK/T-cell lymphoma (ENKTL)

Eligible participants will receive nanatinostat (20mg) orally once daily, on days 1-4 per week with valganciclovir (900mg) orally once daily. Up to 10 PTCL patients will receive nanatinostat (20mg) orally once daily, days 1-4 per week. Treatment cycles are 28-days.

Conditions

This trial is treating patients with relapsed/refractory Epstein-Barr Virus-positive lymphomas

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

NAVAL-1

More information

Trial Identifiers

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Trial sponsor

Viracta Therapeutics, Inc.

Scientific Title

An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

Eligibility

Inclusion

  • EBV+ DLBCL, NOS and PTCL, NOS, and AITL: Relapsed/refractory disease following 1 or more prior systemic therapy(ies) with curative intent.
  • For EBV+ PTLD patients: Relapsed/refractory disease following 1 prior therapy and must have received at least 1 course of an anti-CD20 immunotherapy. For patients with EBV+ PTLD only, age 12 years and older and weighing greater than 40 kg (Adolescent, Adult, Older Adult) are allowed
  • For other EBV+ relapsed/refractory lymphoma: Following at least 1 course of an anit-CD20 immunotherapy and at least 1 course of anthracycline-based chemotherapy (unless contraindicated)
  • No available therapies in the opinion of the Investigator
  • Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy
  • Measurable disease per Cheson 2007
  • ECOG performance status 0, 1, 2
  • Adequate bone marrow function

Exclusion

  • Presence or history of CNS involvement by lymphoma
  • Systemic anticancer therapy or CAR-T within 21 days
  • Antibody (anticancer) agents within 28 days
  • Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant
  • Less than 90 days from prior allogeneic transplant.
  • Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1
  • Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
  • Active infection requiring systemic therapy (excluding viral upper respiratory tract infections).

Inclusion

  • You are able to swallow medication by mouth.
  • 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.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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

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