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An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas
Trial Status: administratively complete
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with
valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Inclusion Criteria
EBV+ DLBCL, NOS and PTCL, NOS, and AITL: Relapsed/refractory disease following 1 or more prior systemic therapy(ies) with curative intent.
For EBV+ PTLD patients: Relapsed/refractory disease following 1 prior therapy and must have received at least 1 course of an anti-CD20 immunotherapy. For patients with EBV+ PTLD only, age 12 years and older and weighing greater than 40 kg (Adolescent, Adult, Older Adult) are allowed
For other EBV+ relapsed/refractory lymphoma: Following at least 1 course of an anit-CD20 immunotherapy and at least 1 course of anthracycline-based chemotherapy (unless contraindicated)
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 Cheson 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.
