An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1) - NAVAL-1

Viracta Therapeutics, Inc.0 个研究点目标入组 150 人开始时间: 2022年5月12日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•1. Adult patients age =18 years at the time of informed consent.
•2. EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies
•3. EBV+ DLBCL, NOS: Must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based
•chemotherapy
•4. PTLD: Must have received immunotherapy with an anti-CD20 agent.
•5. Hodgkin lymphoma: Must have received at least one course of antracycline-based chemotherapy. Patients with classical Hodgkin
•lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy.
•6. For extranodal NK/T-cell lymphoma patients only: Relapsed/refractory disease following 1 or more prior systemic therapies. Patients must have failed an a sparaginase-containing regimen.
•7. No available therapies in the opinion of the investigator.
•8. Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T Therapy.
•9. Measurable disease per Lugano 2007.
•10. ECOG performance status 0, 1, 2.
•11. Adequate bone marrow function.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 112
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 38

•1. Presence or history of central nervous system (CNS) involvement by lymphoma.
•2. Systemic anticancer therapy or CAR within 21 days.
•3. Antibody (anticancer) agents within 28 days.
•4. Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant.
•5. Less than 90 days from prior allogeneic transplant.
•6. Daily corticosteroids (=20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1.
•7. Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
•8. Active infection requiring systemic therapy (Excluding viral upper respiratory tract infections

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