An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
a study on Epstein Barr Virus Lymphoproliferative Disorders EBV-Related PTLD Hodgkin's Lymphoma Lymphoma Non-Hodgkin Lymphoma T Cell Lymphoma EBV-Positive DLBCL EBV Related PTCL
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Orange, California and other locations
- Dates
- study startedestimated completion
Description
Summary
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Details
Patients with EBV-associated lymphomas have inferior outcomes with standard-of-care therapies compared to those with EBV-negative disease. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. This open-label, multicenter, multinational, single-arm, Phase 2 basket study employs a Simon's 2-stage design to allow termination of enrollment into cohorts where treatment appears futile, and will include the following cohorts of patients with EBV+ relapsed/refractory lymphomas:
- EBV+ diffuse large B-cell lymphoma (DLBCL, NOS)
- Extranodal NK/T-cell lymphoma (ENKTL)
- Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL
- Hodgkin lymphoma (HL)
- Post-transplant lymphoproliferative disorder (PTLD)
- HIV-associated lymphomas (Plasmablastic, Burkitt, Hodgkin, DLBCL)
- EBV+ lymphoproliferative disorders other than the above
Keywords
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, EBV positive post-transplant lymphoproliferative disorder (PTLD), EBV lymphoma, HIV-associated lymphoma, Lymphoproliferative Disorders, Epstein-Barr Virus (EBV), EBV positive T cell lymphoma, Epstein-Barr Virus Infections, Lymphoma, T-Cell Lymphoma, Lymphoma, T-Cell, Peripheral, Extranodal NK-T-Cell Lymphoma, Valganciclovir, Nanatinostat in combination with valganciclovir
Eligibility
You can join if…
Open to people ages 18 years and up
- EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies
- EBV+ 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
You CAN'T join if...
- 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).
Locations
- University of California Irvine
accepting new patients
Orange California 92868 United States - David Geffen School of Medicine - UCLA
accepting new patients
Los Angeles California 90095 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Viracta Therapeutics, Inc.
- ID
- NCT05011058
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- Expecting 140 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
Thank you!
The study team should get back to you in a few business days.