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An open-label, phase 2 trial of nanatinostat in combination with valganciclovir in patients with Epstein-Barr virus-positive (EBV+) relapsed/refractory lymphomas.

Description

An phase 2 trial of nanatinostat in combination with valganciclovir in patients with relapsed/refractory, EBV-positive lymphomas.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to determine the objective response rate.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet these criteria:

  • EBV+ relapsed/refractory lymphoma following two 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 one 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

Key Exclusion Criteria:

  • 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).
   

Accepting new patients

 

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