An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

ID#: NCT05011058

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: August 01, 2021

End Date: December 01, 2027

Contact Information:
Strait Hicklin
Summary: A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Eligibility: Key

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 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).