Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated 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, 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: This is an open-label, multicenter, multinational single-arm, Phase 2 basket design study, utilizing Simon's 2-stage design. The study will include 7 cohorts of patients with the following EBV+ relapsed/refractory lymphomas: 1. EBV+ diffuse large B-cell lymphoma (DLBCL, NOS) 2. Extranodal NK/T-cell lymphoma (ENKTL) 3. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL 4. Hodgkin lymphoma (HL) 5. Post-transplant lymphoproliferative disorder (PTLD) 6. HIV-associated lymphomas (Plasmablastic, Burkitt, Hodgkin, DLBCL) 7. 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 Lymphoma Lymphoma, T-Cell Lymphoma, Extranodal NK-T-Cell 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 extranodal NK/T-cell lymphoma patients only: Relapsed/refractory disease following 1 or more prior systemic therapies. 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

  • UCSF Hematology and Blood and Marrow Transplant not yet accepting patients
    San Francisco California 94143 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
Study Type
Interventional
Last Updated