Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

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:

  1. EBV+ diffuse large B-cell lymphoma (DLBCL, NOS)
  2. Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL
  3. Post-transplant lymphoproliferative disorder (PTLD)
  4. EBV+ lymphoproliferative disorders other than the above, including Extranodal NK/T-cell lymphoma (ENKTL)

Keywords

Epstein-Barr Virus Associated Lymphoproliferative Disorder, EBV-Related PTLD, EBV Related Non-Hodgkin's Lymphoma, EBV-Positive DLBCL, NOS, EBV Associated Lymphoma, EBV Related PTCL, NOS, EBV positive post-transplant lymphoproliferative disorder (PTLD), EBV lymphoma, Lymphoproliferative Disorders, Epstein-Barr Virus (EBV), EBV positive T cell lymphoma, EBV positive diffuse large B-cell lymphoma (DLBCL), EBV positive peripheral T-cell lymphoma (PTCL), EBV positive PTLD in Pediatrics, Epstein-Barr Virus Infections, Lymphoma, Valganciclovir, Nanatinostat in combination with valganciclovir

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

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 accepting new patients
    San Francisco California 94143 United States
  • City of Hope accepting new patients
    Duarte California 91010 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