Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, 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

  • David Geffen School of Medicine - UCLA accepting new patients
    Los Angeles California 90095 United States
  • The Oncology Institute of Hope and Innovation withdrawn
    Torrance California 90503 United States
  • City of Hope not yet accepting patients
    Duarte California 91010 United States
  • University of California Irvine accepting new patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Viracta Therapeutics, Inc.
Links
Sign up for this study
ID
NCT05011058
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 140 study participants
Last Updated