EUCTR2020-005197-10-DEActive, not recruitingPhase 1
An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1) - NAVAL-1
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Viracta Therapeutics, Inc.
- Enrollment
- 486
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Adult patients age =18 years or as permitted by applicable local regulations at the time of informed consent. Patients must be able to swallow whole tablets.
- •a. For patients with PTLD: Age =12 years and weighing =40 kg
- •2.EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies
- •3. Patients must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy
- •4.Hodgkin lymphoma: Must have received at least one course of antracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy.
- •5.For patients with ENKTL: Relapsed/ refractory disease following 1 or more prior systemic therapies. Patients must have failed an a sparaginase-containing regimen.
- •6. For patients with PTCL (PTCL, NOS and AITL): relapsed or refractory
- •disease following 1 or more prior systemic therapies with a curative
- •7. For patients with PTLD: Patients with relapsed or refractory EBV+ PTLD who have received at least one prior therapy must have received at least one course of an antiCD20 immunotherapy such as rituximab. For solid-organ transplant (SOT) patients, prior therapy also includes chemotherapy, administered concurrently or sequentially, unless
- •chemotherapy is inappropriate.
- •8.No available therapies in the opinion of the investigator.
- •9.Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T Therapy.
- •10.Measurable disease per Lugano 2007.
- •11.ECOG performance status 0, 1, 2.
- •12.Adequate bone marrow function.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 433
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
Exclusion Criteria
- •1.Presence or history of central nervous system (CNS) involvement by lymphoma.
- •2.Systemic anticancer therapy or CAR within 21 days.
- •3.Antibody (anticancer) agents within 28 days.
- •4.Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant.
- •5.Less than 90 days from prior allogeneic transplant.
- •6.Daily corticosteroids (=20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1.
- •7.Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
- •8.Active infection requiring systemic therapy (Excluding viral upper respiratory tract infections
Investigators
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