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

Trial number:
NCT05011058
Trial phase:
2
Study type:
Targeted therapy
Overall status:
Recruiting

Study start date

May, 2021

Scientific 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

Key

EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapiesEBV+ 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

Presence or history of CNS involvement by lymphomaSystemic 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).

Study design

Primary purpose: Treatment, Allocation: N/A, Intervention model: Single Group Assignment, Intervention model description: This is an open-label, single-arm study utilizing a basket trial design., Masking: None (Open Label),

Conditions

Epstein-Barr Virus Associated Lymphoproliferative Disorder, EBV-Related PTLD, EBV Related Non-Hodgkin's Lymphoma, Extranodal NK/T-cell Lymphoma, EBV-Positive DLBCL, Nos, EBV Associated Lymphoma, EBV-Related Hodgkin Lymphoma, EBV Related PTCL, Nos

Other study ID numbers

VT3996-202

Choose trial site (102)

National Cancer Centre Singapore
National Cancer Centre Singapore Recruiting