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, 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: This is an open-label, multicentre, multinational single-arm, Phase 2 basket design study, utilizing Simon's 2-stage design. The study will include 7 cohorts of patients with the following EBV+ relapsed/refractory lymphomas: 1. EBV+ diffuse large B-cell lymphoma (DLBCL, NOS) 2. Extranodal NK/T-cell lymphoma (ENKTL) 3. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL 4. Hodgkin lymphoma (HL) 5. Post-transplant lymphoproliferative disorder (PTLD) 6. HIV-associated lymphomas (Plasmablastic, Burkitt, Hodgkin, DLBCL) 7. EBV+ lymphoproliferative disorders other than the above

View this trial on ClinicalTrials.gov

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Resources

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