An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas — NAVAL-1  

EBV-Positive DLBCL, NOS Clinical Trial

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

Status Recruiting

Clinical Trial Summary

A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas

Clinical Trial Description

Patients with EBV-associated lymphomas have inferior outcomes with standard-of-care therapies compared to those with EBV-negative disease. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. This open-label, multicenter, multinational, single-arm, Phase 2 basket study employs a Simon's 2-stage design to allow termination of enrollment into cohorts where treatment appears futile, and will include the following cohorts of patients with EBV+ relapsed/refractory lymphomas:

1. EBV+ diffuse large B-cell lymphoma (DLBCL, NOS)

2. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL

3. Post-transplant lymphoproliferative disorder (PTLD)

4. EBV+ lymphoproliferative disorders other than the above, including Extranodal NK/T-cell lymphoma (ENKTL) ;

Related Conditions & MeSH terms

• EBV Associated Lymphoma
• EBV Related Non-Hodgkin's Lymphoma
• EBV-Positive DLBCL, NOS
• EBV-Related PTLD
• Epstein-Barr Virus Associated Lymphoproliferative Disorder
• Epstein-Barr Virus Infections
• Lymphoma
• Lymphoproliferative Disorders

• NCT number: NCT05011058
• Study type: Interventional
• Source: Viracta Therapeutics, Inc.
• Contact: Strait Hicklin
• Phone: 858-400-8470
• Email: ClinicalTrials@Viracta.com
• Status: Recruiting
• Phase: Phase 2
• Start date: May 28, 2021
• Completion date: December 2026