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Nanatinostat + Valganciclovir for EBV-Positive Lymphoma (NAVAL-1 Trial)
NAVAL-1 Trial Summary
This trial is testing a new drug to see if it can help people with a certain kind of lymphoma that has come back or does not respond to other treatments.
NAVAL-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNAVAL-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NAVAL-1 Trial Design
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Who is running the clinical trial?
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- I have had at least one treatment with anti-CD20 and anthracycline for my EBV+ lymphoma.My lymphoma has affected or previously affected my brain or spinal cord.I am not a candidate for intense chemotherapy or specific immune cell therapies.The researcher believes there are no other treatments available for your condition.I haven't taken any anticancer antibody drugs in the last 28 days.I have taken 20 mg or more of corticosteroids daily in the last week.I am over 12, weigh more than 40kg, and my EBV+ PTLD has not improved after 1 treatment including anti-CD20 therapy.I cannot take pills or have a condition that affects how my body absorbs medication.I can take care of myself but might not be able to do heavy physical work.I do not have any infections that need treatment with medications.My EBV+ lymphoma has not responded to at least one treatment.I haven't had cancer treatment or CAR-T therapy in the last 21 days.I am not a candidate for intense chemotherapy or specific immune cell therapies.I had a transplant from a donor less than 3 months ago.My bone marrow is working well.I had a stem cell or organ transplant less than 60 days ago.
- Group 1: Nanatinostat with Valganciclovir
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you please list any other times Nanatinostat has been studied in correlation to valganciclovir?
"The first trial testing the efficacy of nanatinostat in combination with valganciclovir was completed in 2004 at National Institutes of Health Clinical Center. Since then, there have been a total of 42 similar trials completed with 14 more ongoing studies. Many of these active trials are located in Birmingham, Alabama."
How many research facilities are invested in this project?
"21 clinical centres are running this trial, including locations such as The University of Alabama at Birmingham Comprehensive Cancer Center in Birmingham, Mid Florida Hematology and Oncology Center in Orange City, and University of Arizona Cancer Center in Tucson."
What are the usual purposes of taking Nanatinostat in combination with valganciclovir?
"cytomegalovirus retinitis is most effectively treated when Nanatinostat and valganciclovir are used in tandem. This combination therapy can also be helpful for treating other conditions, such as kidney transplants, cardiac transplant patients, and cytomegalovirus infections."
Does Nanatinostat paired with valganciclovir create a health hazard for patients?
"Given that this is a phase 2 trial, meaning there is only preliminary data supporting safety and no efficacy data, our team has rated the Nanatinostat/valganciclovir combination as being a 2 on our risk scale."
Are new participants being accepted for this clinical trial?
"Yes, that is accurate. The study in question is recruiting patients at the moment, as reflected on clinicaltrials.gov. This specific trial was first posted on 5/28/2021 and updated for the last time on 10/18/2022. They are looking to enroll a total of 140 people across 21 locations."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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