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Histone Deacetylase (HDAC) Inhibitor

Nanatinostat + Valganciclovir for EBV-Positive Lymphoma (NAVAL-1 Trial)

Phase 2
Recruiting
Research Sponsored by Viracta Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0, 1, 2
EBV+ DLBCL, NOS and PTCL, NOS, and AITL: Relapsed/refractory disease following 1 or more prior systemic therapy(ies) with curative intent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights

NAVAL-1 Trial Summary

This trial is testing a new drug to see if it can help people with a certain kind of lymphoma that has come back or does not respond to other treatments.

Who is the study for?
This trial is for patients with Epstein-Barr Virus-positive lymphomas who have tried at least two prior treatments and aren't eligible for high-dose chemotherapy or stem cell/CAR-T therapies. They should not be candidates for other available therapies, have measurable disease, a decent performance status, and good bone marrow function. Those with CNS lymphoma involvement or recent anticancer therapy are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of nanatinostat combined with valganciclovir in those whose EBV+ lymphoma has returned after treatment or hasn't responded to previous treatments. It's an open-label Phase 2 trial where all participants receive the same experimental therapy.See study design
What are the potential side effects?
Potential side effects may include issues related to bone marrow suppression (like low blood counts), gastrointestinal symptoms (nausea, diarrhea), fatigue, and possible drug-specific reactions that will be monitored throughout the trial.

NAVAL-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My EBV+ lymphoma has not responded to at least one treatment.
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I am not a candidate for intense chemotherapy or specific immune cell therapies.

NAVAL-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Duration of response (DOR)
Incidence and severity of treatment-emergent adverse events
Overall survival
+6 more

NAVAL-1 Trial Design

1Treatment groups
Experimental Treatment
Group I: Nanatinostat with ValganciclovirExperimental Treatment1 Intervention
Patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week with valganciclovir 900 mg orally once daily. Up to 10 PTCL patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week.

Find a Location

Who is running the clinical trial?

Viracta Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
208 Total Patients Enrolled
Lisa Rojkjaer, MDStudy DirectorViracta Therapeutics
1 Previous Clinical Trials
130 Total Patients Enrolled
Donald (D.K.) Strickland, MDStudy DirectorViracta Therapeutics

Media Library

Nanatinostat (Histone Deacetylase (HDAC) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05011058 — Phase 2
Lymphoma Research Study Groups: Nanatinostat with Valganciclovir
Lymphoma Clinical Trial 2023: Nanatinostat Highlights & Side Effects. Trial Name: NCT05011058 — Phase 2
Nanatinostat (Histone Deacetylase (HDAC) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05011058 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please list any other times Nanatinostat has been studied in correlation to valganciclovir?

"The first trial testing the efficacy of nanatinostat in combination with valganciclovir was completed in 2004 at National Institutes of Health Clinical Center. Since then, there have been a total of 42 similar trials completed with 14 more ongoing studies. Many of these active trials are located in Birmingham, Alabama."

Answered by AI

How many research facilities are invested in this project?

"21 clinical centres are running this trial, including locations such as The University of Alabama at Birmingham Comprehensive Cancer Center in Birmingham, Mid Florida Hematology and Oncology Center in Orange City, and University of Arizona Cancer Center in Tucson."

Answered by AI

What are the usual purposes of taking Nanatinostat in combination with valganciclovir?

"cytomegalovirus retinitis is most effectively treated when Nanatinostat and valganciclovir are used in tandem. This combination therapy can also be helpful for treating other conditions, such as kidney transplants, cardiac transplant patients, and cytomegalovirus infections."

Answered by AI

Does Nanatinostat paired with valganciclovir create a health hazard for patients?

"Given that this is a phase 2 trial, meaning there is only preliminary data supporting safety and no efficacy data, our team has rated the Nanatinostat/valganciclovir combination as being a 2 on our risk scale."

Answered by AI

Are new participants being accepted for this clinical trial?

"Yes, that is accurate. The study in question is recruiting patients at the moment, as reflected on clinicaltrials.gov. This specific trial was first posted on 5/28/2021 and updated for the last time on 10/18/2022. They are looking to enroll a total of 140 people across 21 locations."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~43 spots leftby Jul 2025