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Epstein-Barr Virus Associated LymphomaPhase 2NAVAL-1NCT05011058

An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas

A Phase 2 study testing Nanatinostat in combination with valganciclovir in people with Epstein-Barr Virus Associated Lymphoma and EBV-Positive DLBCL, NOS, run by Viracta Therapeutics, Inc. at 62 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Nanatinostat in combination with valganciclovir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
62 sitesin 14 countries
Study dates
28 May 2021to 31 Jan 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

62 sites in 14 countries.

62 sites in 14 countries

United States17 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • The University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Ohio State University: Wexner Medical Center

    Columbus, Ohio, 43210

  • Harold C. Simmons Comprehensive Cancer Center

    Dallas, Texas, 75235

  • City of Hope

    Duarte, California, 91010

  • John Theurer Cancer Center: Hackensack Univeristy

    Hackensack, New Jersey, 07601

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • David Geffen School of Medicine - UCLA

    Los Angeles, California, 90095

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • University of California Irvine

    Orange, California, 92868

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia, Pennsylvania, 19107

  • University of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Scripps MD Anderson Cancer Center

    San Diego, California, 92103

  • UCSF Hematology and Blood and Marrow Transplant

    San Francisco, California, 94143

Other trials in United States

Italy9 sites

  • Centro di Riferimento Oncologico

    Aviano, Pordenone

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

    Bologna

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan

  • Istituto Europeo di Oncologia

    Milan

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

  • Arcispedale Santa Maria Nuova

    Reggio Emilia

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma

  • Istituto Clinico Humanitas

    Rozzano, Milan

Other trials in Italy

France6 sites

  • Institut Bergonié

    Bordeaux, Aquitaine

  • Centre Hospitalier Universitaire Limoges

    Limoges, Limousin

  • Henri Mondor University Hospital

    Paris

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, Île-de-France Region

  • Hôpital Haut-Lévêque

    Pessac, New Aquitaine

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Rhone-Alps

Other trials in France

Brazil5 sites

  • CEPEVILLE - Instituto Joinvilense de Hematologia e Oncologia

    Joinville

  • Ruschel Medicina e Pesquisa Clinica

    Rio de Janeiro

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André

  • CIPE Centro Internacional de Pesquisa - AC Camargo Cancer Center

    São Paulo

  • HCFMUSP - Hospital das Clínicas da Faculdade de Medicina Universidade de São Paulo

    São Paulo

Other trials in Brazil

Taiwan5 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Chang Gung Memorial Hospital - Linkou Branch

    Taoyuan City

Other trials in Taiwan

Canada3 sites

  • Cross Cancer Institute

    Edmonton, Alberta

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec

  • BC Cancer Agency

    Vancouver, British Columbia

Other trials in Canada

Singapore3 sites

  • National Cancer Centre Singapore

    Singapore

  • Oncocare Cancer Center

    Singapore

  • Singapore General Hospital

    Singapore

Other trials in Singapore

Spain3 sites

  • Hospitalet de Llobregat

    Barcelona

  • Hospital Universitario 12 de Octubre

    Madrid

  • Jimenez Diaz Foundation University Hospital

    Madrid

Other trials in Spain

United Kingdom3 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool

  • University College London Hospitals NHS Foundation Trust

    London

  • The Christie NHS Foundation Trust

    Manchester

Other trials in United Kingdom

Australia2 sites

  • Box Hill Hospital

    Melbourne, Victoria

  • The Alfred Hospital

    Melbourne, Victoria

Other trials in Australia

Germany2 sites

  • Universitätsklinikum Leipzig

    Leipzig

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria

Other trials in Germany

South Korea2 sites

  • Gachon University Gil Medical Center

    Incheon

  • Samsung Medical Center

    Seoul

Other trials in South Korea

Israel1 site

  • Hadassah Medical Center, Ein Kerem Hospital

    Jerusalem

Other trials in Israel

Malaysia1 site

  • Sarawak General Hospital / Hospital Umum Sarawak

    Kuching

Other trials in Malaysia

About this study

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

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

Read the detailed 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. Diffuse large B-cell lymphoma (DLBCL)
  2. Extranodal natural killer/T-cell lymphoma (ENKTL)
  3. Peripheral T-cell lymphoma (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS)
  4. Hodgkin lymphoma (HL)
  5. Post-transplant lymphoproliferative disorders (PTLD)
  6. Human immunodeficiency virus (HIV)-associated lymphomas (HIV-L)
  7. EBV+ lymphomas other than the above

The study was terminated prematurely and did not reach its target enrollment.

Being tested
Nanatinostat in combination with valganciclovir
Keywords
Epstein-Barr virus (EBV), EBV-positive lymphomas, EBV-positive T-cell lymphoma, EBV-positive Hodgkin lymphoma, EBV-positive diffuse large B-cell lymphoma (DLBCL), EBV-positive extranodal natural killer/T-cell lymphoma, EBV-positive peripheral T-cell lymphoma (PTCL), EBV-positive post-transplant lymphoproliferative disorders
Medical subject headings
Pyloric Stenosis, Hypertrophic, Epstein-Barr Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nanatinostat in combination with valganciclovirDrug

    Also called VRx-3996 in combination with Valcyte

    Drug: Nanatinostat, 20 mg orally once daily, 4 days per week in 28 day cycles

    Drug: Valganciclovir, 900 mg orally once daily in 28 day cycles

Study groups in NCT05011058
Study groupRoleWhat they receive
Nanatinostat with ValganciclovirExperimentalPatients 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.
Receives: Drug: Nanatinostat in combination with valganciclovir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the 2007 International Working Group (IWG) criteria, where CR included complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy with all lymph nodes and nodal masses having regressed on computed tomography to normal size, and PR included at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, no increase should have been observed in the size of other nodes, liver, or spleen, and splenic and hepatic nodules must have regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.

    Measured: Up to approximately 2 years

Secondary outcomes (10)

  1. Duration of Response (DOR)

    Interval of time from date of first observed complete or partial response per 2007 International Working Group (IWG) criteria to the date of documented disease progression or death due to any cause, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. DOR was censored at the time of study withdrawal for hematopoietic stem cell transplant, or at the time of study termination, whichever was earlier, for patients whose disease was still in response.

    Measured: Up to approximately 2 years

  2. Time to Next Anti-Lymphoma Treatment (TTNLT)

    Interval of time from the start of study drug treatment to the date of next anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy).

    Measured: Up to approximately 3 years

  3. Time to Progression (TTP)

    Interval of time from the start of study drug treatment to the date of disease progression, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. TTP was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression.

    Measured: Up to approximately 3 years

  4. Progression-Free Survival (PFS)

    Interval of time from the start of study drug treatment to the date of first documented disease progression (defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir), initiation of new antineoplastic therapy, or death from any cause, whichever occurred first. PFS was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression or death.

    Measured: Up to approximately 3 years

  5. Overall Survival (OS)

    Interval of time from the start of study drug treatment to the date of death for any reason. OS was censored at the time of study withdrawal or study termination, whichever was earlier, for patients without reported death.

    Measured: Up to approximately 3 years

  6. Number (Percentage) of Participants With Adverse Events (AEs)

    Number (percentage) of patients experiencing at least one treatment-emergent adverse event, defined as those untoward medical events with onset after the first dose of study drug or existing events that worsened after the first dose during the study

    Measured: Up to approximately 2 years

  7. Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax]

    Defined as the time required to reach peak plasma concentration [Cmax] after study drug administration

    Measured: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

  8. Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax]

    Defined as the peak plasma concentration [Cmax] after study drug administration

    Measured: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

  9. Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t]

    Defined as the area under the concentration-time curve from time 0 to the last measurable plasma concentration

    Measured: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

  10. Pharmacokinetic (PK) Parameter - Half-Life [t1/2]

    Defined as the time required to reduce plasma concentration by 50% after study drug administration

    Measured: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start28 May 2021
  3. Primary completion26 Dec 2024
  4. Study completion31 Jan 2025

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open-label, single-arm study utilizing a basket trial design. The study was terminated prematurely and did not reach its target enrollment.
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05011058
Sponsor's protocol ID
VT3996-202
Acronym
NAVAL-1
Status last verified
Jul 2025
First submitted
2 Aug 2021
Last updated
28 Jul 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

    PubMed 17242396

  • Haverkos B, Alpdogan O, Baiocchi R, Brammer JE, Feldman TA, Capra M, Brem EA, Nair S, Scheinberg P, Pereira J, Shune L, Joffe E, Young P, Spruill S, Katkov A, McRae R, Royston I, Faller DV, Rojkjaer L, Porcu P. Targeted therapy with nanatinostat and valganciclovir in recurrent EBV-positive lymphoid malignancies: a phase 1b/2 study. Blood Adv. 2023 Oct 24;7(20):6339-6350. doi: 10.1182/bloodadvances.2023010330.

    PubMed 37530631

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nanatinostat in combination with valganciclovir in people with Epstein-Barr Virus Associated Lymphoma and EBV-Positive DLBCL, NOS, run by Viracta Therapeutics, Inc. at 62 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Italy, France, Brazil, Taiwan and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05011058, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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