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 UC Irvine UCLA UCSF
- 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
- David Geffen School of Medicine - UCLA
accepting new patients
Los Angeles California 90095 United States - University of California Irvine
accepting new patients
Orange California 92868 United States - UCSF Hematology and Blood and Marrow Transplant
accepting new patients
San Francisco California 94143 United States - Scripps MD Anderson Cancer Center
accepting new patients
San Diego California 92103 United States - The Oncology Institute of Hope and Innovation
accepting new patients
Torrance California 90503 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