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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512717-41-00

Acronym

VT3996-202

Enrollment

Registered

2024-06-25

Start date

2021-10-01

Completion date

2024-12-26

Last updated

2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

Brief summary

Objective response rate (ORR) as assessed by an Independent Review Committee (IRC) per the 2007 International Working Group (IWG) criteria.

Detailed description

1. Duration of response (DOR), 2. Time to next anti-lymphoma treatment, 3. Progression-free survival, 4. Time to progression, 5. Overall survival (OS), 6. Pharmacokinetic (PK) parameters (eg, time to maximum plasma concentration [tmax], maximum plasma concentration [Cmax], area under the plasma concentration-time curve [AUC]).

Interventions

DRUGNanatinostat

DRUGVALGANCICLOVIR

DRUGGANCICLOVIR

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) as assessed by an Independent Review Committee (IRC) per the 2007 International Working Group (IWG) criteria.	—

Secondary

Measure	Time frame
1. Duration of response (DOR), 2. Time to next anti-lymphoma treatment, 3. Progression-free survival, 4. Time to progression, 5. Overall survival (OS), 6. Pharmacokinetic (PK) parameters (eg, time to maximum plasma concentration [tmax], maximum plasma concentration [Cmax], area under the plasma concentration-time curve [AUC]).	—

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026