Clinical trial · Interventional
An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
NCT05011058CI-TRIAL-00092686NAVAL-1terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EBV-Positive DLBCL, NOS | EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | ALIAS | 0.90 |
| EBV-Related Hodgkin Lymphoma | EBV-Related Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| EBV-Related Lymphoproliferative Disorder | — | UNRESOLVED | — |
| EBV-Related Non-Hodgkin Lymphoma | EBV-Related Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| EBV Related PTCL, NOS | — | UNRESOLVED | — |
| EBV-Related PTLD | — | UNRESOLVED | — |
| Epstein-Barr Virus Associated Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nanatinostat in combination with valganciclovir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nanatinostat with Valganciclovir
- description
- 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.
- interventionNames
- Drug: Nanatinostat in combination with valganciclovir
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to approximately 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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).
References
Publications (2)
- BACKGROUNDCheson 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. PMID 17242396
- DERIVEDHaverkos 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. PMID 37530631