Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
People with Epstein-Barr Virus (EBV) associated lymphomas have inferior outcomes with standard of care therapies compared to those eith EBV-negative disease. This study is evaluating the efficacy of nanatinostat in combination with valganciclovir in people with relapsed/refractory EBV-positive lymphomas. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form.
The study will include the following cohorts if people with EBV+ relapsed/refractory lymphomas:
- EBV+ diffuse large B-cell lymphoma (DLBCL, NOS)
- Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL
- Post-transplant lymphoproliferative disorder (PTLD)
- EBV+ lymphoproliferative disorders other than the above, including Extranodal NK/T-cell lymphoma (ENKTL)
Eligible participants will receive nanatinostat (20mg) orally once daily, on days 1-4 per week with valganciclovir (900mg) orally once daily. Up to 10 PTCL patients will receive nanatinostat (20mg) orally once daily, days 1-4 per week. Treatment cycles are 28-days.
Conditions
This trial is treating people with relapsed/refractory Epstein-Barr Virus-positive lymphomas
Eligibility
Inclusion
- 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
- 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).
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Viracta Therapeutics, Inc.
Scientific Title
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
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