An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

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

Summary:

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

Trial Description

Primary Outcome:

• Objective response rate (ORR)

Secondary Outcome:

• Duration of response (DOR)
• Time to next anti-lymphoma treatment (TTNLT)
• Progression-free survival (PFS)
• Time to progression (TTP)
• Overall survival
• Incidence and severity of treatment-emergent adverse events
• Pharmacokinetic parameter - time to maximum plasma concentration [tmax],
• Pharmacokinetic parameter - maximum plasma concentration [Cmax]
• Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC]

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, multicentre, 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: EBV+ diffuse large B-cell lymphoma (DLBCL, NOS) Extranodal NK/T-cell lymphoma (ENKTL) Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL Hodgkin lymphoma (HL) Post-transplant lymphoproliferative disorder (PTLD) HIV-associated lymphomas (Plasmablastic, Burkitt, Hodgkin, DLBCL) EBV+ lymphoproliferative disorders other than the above

View this trial on ClinicalTrials.gov