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Study on Nanatinostat and Valganciclovir for Patients with Epstein-Barr Virus-Positive Relapsed or Refractory Lymphomas

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas. This condition involves a group of cancers that have returned or are resistant to treatment and are associated with the Epstein-Barr virus. The trial is testing a combination of two medications: Nanatinostat and Valganciclovir. Nanatinostat, also known by its code name VRx-3996, is a chemical compound taken as a coated tablet. Valganciclovir is another chemical compound used in this study, also taken orally.

The purpose of the study is to evaluate how well the combination of Nanatinostat and Valganciclovir works in treating these lymphomas. Participants in the study will receive these medications over a period of time, and their response to the treatment will be monitored. The study aims to see if the combination can reduce the size of the tumors or slow their growth. The trial will also look at how long the response lasts, the time until the next treatment is needed, and overall survival rates.

Throughout the study, participants will be closely observed to assess the effectiveness of the treatment and any side effects. The trial is designed to gather information on how the body processes the medications, including how long it takes for the drugs to reach their highest concentration in the blood and how long they stay in the system. This information will help determine the potential benefits of the treatment for patients with EBV+ relapsed/refractory lymphomas.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, eligibility is confirmed based on specific criteria, such as age, previous treatments, and current health status.
The trial is designed for patients with Epstein-Barr Virus-Positive (EBV+) relapsed or refractory lymphomas.
Step 2
Treatment initiation
The treatment involves a combination of two medications: nanatinostat and valganciclovir.
Nanatinostat is administered orally in the form of coated tablets.
Valganciclovir is also taken orally.
Step 3
Medication schedule
The specific dosage and frequency of nanatinostat and valganciclovir are determined by the healthcare provider based on individual patient needs.
Regular monitoring and adjustments may be made to optimize treatment effectiveness.
Step 4
Treatment duration
The treatment continues until the healthcare provider determines it is no longer beneficial or until the trial's estimated end date in June 2025.
Regular assessments are conducted to evaluate the response to the treatment.
Step 5
Evaluation and monitoring
The primary goal is to assess the objective response rate, which measures how well the tumor responds to the treatment.
Secondary evaluations include the duration of response, time to next treatment, progression-free survival, and overall survival.
Pharmacokinetic parameters, such as the time to maximum plasma concentration, are also monitored.

Who can join the trial?

12 criteria

Patients must be adults aged 18 years or older, or as allowed by local regulations. They must be able to swallow whole tablets. For patients with PTLD, they must be at least 12 years old and weigh at least 40 kg.
Patients must have Epstein-Barr Virus-Positive (EBV+) lymphoma that has returned or not responded to treatment after two or more previous treatments.
Patients must have received at least one treatment with anti-CD20 immunotherapy and one treatment with anthracycline-based chemotherapy. Anti-CD20 immunotherapy is a type of treatment that targets specific proteins on cancer cells, and anthracycline-based chemotherapy is a common cancer treatment.
For Hodgkin lymphoma patients, they must have received at least one treatment with anthracycline-based chemotherapy. If they have classical Hodgkin lymphoma, they should have either not responded to or be ineligible for anti-PD-1 therapy and CD30-directed therapy. Anti-PD-1 therapy and CD30-directed therapy are specific types of cancer treatments.
For patients with ENKTL (a type of lymphoma), they must have relapsed or refractory disease after one or more previous treatments and must have not responded to a treatment containing asparaginase, which is a type of enzyme used in cancer treatment.
For patients with PTCL (another type of lymphoma), they must have relapsed or refractory disease after one or more previous treatments with the intent to cure. In France, they must have had two or more treatments.
For patients with PTLD (a type of lymphoma related to organ transplants), they must have relapsed or refractory EBV+ PTLD after at least one previous treatment, including at least one course of anti-CD20 immunotherapy like rituximab. For those with solid-organ transplants, previous treatment should also include chemotherapy unless it is not suitable.
There should be no other available therapies, according to the investigator's opinion.
Patients should not be eligible for high-dose chemotherapy with stem cell transplantation or CAR-T Therapy. These are advanced treatments for cancer.
Patients must have a measurable disease according to the Lugano 2007 criteria, which is a standard way to assess the size and spread of cancer.
Patients must have an ECOG performance status of 0, 1, or 2. This is a scale used to assess how a patient's disease is affecting their daily living abilities, with 0 being fully active and 2 being able to do all self-care but unable to work.
Patients must have adequate bone marrow function, meaning their bone marrow is working well enough to produce blood cells.

Who cannot join the trial?

7 criteria

Patients who have a different type of lymphoma that is not related to the Epstein-Barr Virus (EBV). EBV is a virus that can cause certain types of cancer.
Patients who have not experienced a return or worsening of their lymphoma after treatment. This is known as relapsed/refractory lymphoma, meaning the cancer has come back or is not responding to treatment.
Patients who are not within the specified age range for the study. The study may have specific age requirements.
Patients who are not able to follow the study procedures or take the study medications as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
Patients who are participating in another clinical trial at the same time, as this could affect the results of the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Verified
Azienda USL IRCCS Di Reggio Emilia
Reggio Emilia, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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Investigated drugs

Nanatinostat
is a medication being studied for its potential to treat certain types of lymphomas that are positive for the Epstein-Barr Virus (EBV). It is being tested to see how well it can help reduce or eliminate tumors when used in combination with another medication.
Valganciclovir
is another medication used in this study. It is typically used to treat infections caused by viruses, and in this trial, it is combined with nanatinostat to see if the two together can improve the treatment outcomes for patients with EBV-positive lymphomas.

What is already known about the treatment

Nanatinostat
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating Epstein-Barr Virus-Positive (EBV+) relapsed or refractory lymphomas. It is not yet widely used in standard medical practice, as it is still under investigation. Nanatinostat works by inhibiting specific enzymes that modify the structure of DNA, which can help stop the growth of cancer cells. It is classified as a histone deacetylase inhibitor, a type of drug that affects gene expression and cell cycle regulation.
Valganciclovir
This medication is taken orally and is being evaluated in combination with nanatinostat for its potential to treat Epstein-Barr Virus-Positive (EBV+) relapsed or refractory lymphomas. Valganciclovir is an antiviral medication that is already used in medical practice to treat infections caused by certain viruses. It works by interfering with the replication of viral DNA, thereby reducing the spread of the virus. It is classified as an antiviral agent, specifically a nucleoside analog.

Investigated diseases

Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas – This disease is a type of cancer that affects the lymphatic system and is associated with the Epstein-Barr virus. It occurs when lymphoma, a cancer of the lymph nodes, returns or does not respond to initial treatment. The disease can involve various types of lymphomas, such as Hodgkin or non-Hodgkin lymphoma, that test positive for the presence of the Epstein-Barr virus. As the disease progresses, it may cause symptoms like swollen lymph nodes, fever, night sweats, and weight loss. The progression can vary, with some cases advancing more rapidly than others. The disease is considered challenging to treat due to its resistance to standard therapies.