An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas
Megadott ok: Sponsor Decision
Key facts
- Where
- Aurora, Baltimore, Birmingham, Charleston, Cincinnati, Columbus, Dallas, Duarte, Hackensack, Houston, Los Angeles, New York, Orange, Philadelphia, Salt Lake City, San Diego és San Francisco, Egyesült ÁllamokSee the 17 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- University of Colorado Cancer CenterAurora, Egyesült ÁllamokNo longer taking part
- University of Maryland Medical CenterBaltimore, Egyesült ÁllamokNo longer taking part
- The University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Egyesült ÁllamokNo longer taking part
- Medical University of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
- Cincinnati Children's Hospital Medical CenterCincinnati, Egyesült ÁllamokNo longer taking part
- Ohio State University Wexner Medical CenterColumbus, Egyesült ÁllamokNo longer taking part
- Harold C. Simmons Comprehensive Cancer CenterDallas, Egyesült ÁllamokNo longer taking part
- City of HopeDuarte, Egyesült ÁllamokNo longer taking part
- John Theurer Cancer Center: Hackensack UniveristyHackensack, Egyesült ÁllamokNo longer taking part
- The University of Texas MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- David Geffen School of Medicine, UCLALos Angeles, Egyesült ÁllamokNo longer taking part
- Icahn School of Medicine at Mount SinaiNew York, Egyesült ÁllamokNo longer taking part
- University of California IrvineOrange, Egyesült ÁllamokNo longer taking part
- Sidney Kimmel Cancer Center - Jefferson HealthPhiladelphia, Egyesült ÁllamokNo longer taking part
- University of Utah - Huntsman Cancer InstituteSalt Lake City, Egyesült ÁllamokNo longer taking part
- Scripps MD Anderson Cancer CenterSan Diego, Egyesült ÁllamokNo longer taking part
- UCSF Hematology and Blood and Marrow TransplantSan Francisco, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Viracta Therapeutics, Inc.
- Trial code
- NCT05011058
- Record updated
- 2025. július 28.
- Original description
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomasRead full original descriptionShow less
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Inclusion: 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.
Exclusion: 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; Presence or history of 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).