An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
Purpose
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Conditions
- 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned 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. |
|
Recruiting Locations
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- Viracta Therapeutics, Inc.
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. 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)