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Purpose

A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

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).

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
This is an open-label, single-arm study utilizing a basket trial design. The study was terminated prematurely and did not reach its target enrollment.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nanatinostat with Valganciclovir 		Patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week with valganciclovir 900 mg orally once daily. Up to 10 PTCL patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week.
  • Drug: Nanatinostat in combination with valganciclovir
    Drug: Nanatinostat, 20 mg orally once daily, 4 days per week in 28 day cycles Drug: Valganciclovir, 900 mg orally once daily in 28 day cycles
    Other names:
    • VRx-3996 in combination with Valcyte

More Details

Status
Terminated
Sponsor
Viracta Therapeutics, Inc.

Study Contact

Detailed Description

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. Diffuse large B-cell lymphoma (DLBCL) 2. Extranodal natural killer/T-cell lymphoma (ENKTL) 3. Peripheral T-cell lymphoma (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS) 4. Hodgkin lymphoma (HL) 5. Post-transplant lymphoproliferative disorders (PTLD) 6. Human immunodeficiency virus (HIV)-associated lymphomas (HIV-L) 7. EBV+ lymphomas other than the above The study was terminated prematurely and did not reach its target enrollment.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.