Open Actively Recruiting
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Key Inclusion Criteria:
- EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies
- EBV+ DLBCL, NOS: Must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy
- PTLD: Must have received immunotherapy with an anti-CD20 agent.
- Hodgkin lymphoma: Must have received at least one course of anthracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy.
- For ENKTL and PTCL patients only: Relapsed/refractory disease following 1 or more prior systemic therapies. ENKTL patients must have failed an asparaginase-containing regimen.
- 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 Lugano 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).
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- UCLA Westwood