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

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT05011058
Trial Phases:	Phase II	Protocol IDs:	VT3996-202 (primary) NCI-2021-09770
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Viracta Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05011058

Summary

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

Objectives

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)

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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