Purpose of this Study
We are doing this study to find out if the combination of two drugs called nanatinostat and valganciclovir (the study drugs) are a safe and effective option for treating lymphoma in people who are EBV-positive. We will use different doses of the study drugs to determine what dose appears to be ideal for most people. The safety and effectiveness of nanatinostat on its own will also be tested in a small number of study participants.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with lymphoma and confirmed to be EBV-positive</li>
<li>Are not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: terri.lucas@duke.edu">terri.lucas@duke.edu</a> or 919-681-6580.
<li>Are diagnosed with lymphoma and confirmed to be EBV-positive</li>
<li>Are not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: terri.lucas@duke.edu">terri.lucas@duke.edu</a> or 919-681-6580.
What is Involved?
If you choose to join this study, you will go through a screening visit. During this screening visit, you will:<ul>
<li>Answer questionnaires</li>
<li>Have a physical exam</li>
<li>Have blood draws</li>
<li>Have a heart scan (ECG)</li>
<li>Have a bone marrow biopsy</li>
<li>Have imaging done (CT or MRI)</li></ul>
If you are eligible to join the study, the dose and type of study drugs you receive will be based on the category of your lymphoma. You may participate in the study for as long as you do not experience severe side effects and are able to come to the clinic for study visits.
<li>Answer questionnaires</li>
<li>Have a physical exam</li>
<li>Have blood draws</li>
<li>Have a heart scan (ECG)</li>
<li>Have a bone marrow biopsy</li>
<li>Have imaging done (CT or MRI)</li></ul>
If you are eligible to join the study, the dose and type of study drugs you receive will be based on the category of your lymphoma. You may participate in the study for as long as you do not experience severe side effects and are able to come to the clinic for study visits.
Study Details
Full Title
Viracta: 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)
Principal Investigator
Matthew
McKinney
Protocol Number
PRO00112718
NCT ID
NCT05011058
Phase
II
Enrollment Status
Open to Enrollment