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

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.