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)
Key facts
- Where
- Aviano, Bologna, Brescia, Milan, Pavia, Reggio Emilia, Rome, Rozzano és San Giovanni Rotondo, OlaszországSee the 10 sites
- Phase
- 2. fázis
Where in Olaszország
- Centro di Riferimento Oncologico di AvianoAviano, OlaszországNo longer taking part
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, OlaszországNo longer taking part
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, OlaszországNo longer taking part
- ASST Grande Ospedale Metropolitano NiguardaMilan, OlaszországNo longer taking part
- Istituto Europeo di Oncologia s.r.lMilan, OlaszországNo longer taking part
- Fondazione IRCCS Policlinico San MatteoPavia, OlaszországNo longer taking part
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, OlaszországNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországNo longer taking part
- Humanitas Mirasole S.p.A.Rozzano, OlaszországNo longer taking part
- Casa Sollievo della SofferenzaSan Giovanni Rotondo, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Viracta Therapeutics Inc.
- Trial code
- EU 2024-512717-41-00
- Record updated
- 2024. szeptember 5.
- Original description
To evaluate the anti-tumor activity of the combination treatment of nanatinostat (Nstat) with valganciclovir (VGCV) based on objective tumor response ratesRead full original descriptionShow less
To evaluate the anti-tumor activity of the combination treatment of nanatinostat (Nstat) with valganciclovir (VGCV) based on objective tumor response rates
Inclusion: Adult patients age ≥18 years or as permitted by applicable local regulations at the time of providing informed consent. Patients must be able to swallow whole tablets. a. For patients with PTLD: Age ≥12 years and weighing ≥40 kg; Measurable disease per Lugano 2007; ECOG performance status 0, 1, 2; Adequate bone marrow function; EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies; Patients must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy; 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; For patients with ENKTL: Relapsed/refractory disease following 1 or more prior systemic therapies. Patients must have failed an a sparaginase-containing regimen; For patients with PTCL (PTCL, NOS and AITL): relapsed or refractory disease following 1 (2 for France) or more prior systemic therapies with a curative intent; For patients with PTLD: Patients with relapsed or refractory EBV+ PTLD who have received at least one prior therapy must have received at least one course of an antiCD20 immunotherapy such as rituximab. For solid-organ transplant (SOT) patients, prior therapy also includes chemotherapy, administered concurrently or sequentially, unless chemotherapy is inappropriate; 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.
Exclusion: Systemic anticancer therapy or CAR 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; Presence or history of central nervous system (CNS) involvement by lymphoma; 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.