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

VT3996-202

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

2021-05-28

2025-07-01

2026-12-01

Recruiting

Early phase I

140

Key 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. * Active infection requiring systemic therapy (excluding viral upper respiratory tract infections).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an open-label, single-arm study utilizing a basket trial design.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

2024-05-01