What side effects are associated with this type of intervention?

Common treatments for lymphoma, particularly those involving Histone Deacetylase Inhibitors like Nanatinostat and antivirals like Valganciclovir, are associated with several side effects. HDAC inhibitors often cause fatigue, nausea, vomiting, diarrhea, thrombocytopenia, neutropenia, and anemia. Valganciclovir typically leads to neutropenia, anemia, thrombocytopenia, diarrhea, nausea, and renal toxicity. Patients undergoing these treatments should be closely monitored for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several Histone Deacetylase Inhibitors (HDAC inhibitors) for the treatment of lymphoma. Notable examples include Vorinostat (Zolinza), Romidepsin (Istodax), and Belinostat (Beleodaq), which are used in various types of peripheral T-cell lymphoma and cutaneous T-cell lymphoma. These drugs work by inhibiting the activity of histone deacetylases, leading to cell cycle arrest and apoptosis in cancer cells. Valganciclovir, an antiviral, is not directly approved for lymphoma treatment but is used to manage cytomegalovirus (CMV) infections in immunocompromised patients, including those undergoing treatment for lymphoma.

What other types of research exist?

Promising novel alternatives for lymphoma treatment in 2024 include: 1) CAR T-cell therapies, such as axicabtagene ciloleucel and tisagenlecleucel, which have shown significant efficacy in relapsed/refractory lymphomas. 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which target CD19 on B-cells and engage T-cells to kill cancer cells. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which deliver cytotoxic agents directly to cancer cells. 4) Novel small molecule inhibitors like Bruton tyrosine kinase (BTK) inhibitors (e.g., zanubrutinib) and BCL-2 inhibitors (e.g., venetoclax) that target specific pathways in lymphoma cells.

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Histone Deacetylase (HDAC) Inhibitor

Nanatinostat + Valganciclovir for EBV-Positive Lymphoma (NAVAL-1 Trial)

Phase 2

Recruiting

Research Sponsored by Viracta Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0, 1, 2

EBV+ DLBCL, NOS and PTCL, NOS, and AITL: Relapsed/refractory disease following 1 or more prior systemic therapy(ies) with curative intent

Must not have

Presence or history of CNS involvement by lymphoma

Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of nanatinostat and valganciclovir in patients with relapsed or refractory EBV-positive lymphomas. Nanatinostat helps the virus produce proteins that activate valganciclovir to kill cancer cells. The goal is to improve outcomes for these patients. Nanatinostat has shown promise in making EBV-positive lymphoma cells more responsive to antiviral agents.

Who is the study for?

This trial is for patients with Epstein-Barr Virus-positive lymphomas who have tried at least two prior treatments and aren't eligible for high-dose chemotherapy or stem cell/CAR-T therapies. They should not be candidates for other available therapies, have measurable disease, a decent performance status, and good bone marrow function. Those with CNS lymphoma involvement or recent anticancer therapy are excluded.

What is being tested?

The study tests the effectiveness of nanatinostat combined with valganciclovir in those whose EBV+ lymphoma has returned after treatment or hasn't responded to previous treatments. It's an open-label Phase 2 trial where all participants receive the same experimental therapy.

What are the potential side effects?

Potential side effects may include issues related to bone marrow suppression (like low blood counts), gastrointestinal symptoms (nausea, diarrhea), fatigue, and possible drug-specific reactions that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My EBV+ lymphoma has not responded to at least one treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lymphoma has affected or previously affected my brain or spinal cord.

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I have taken 20 mg or more of corticosteroids daily in the last week.

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I do not have any infections that need treatment with medications.

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I haven't had cancer treatment or CAR-T therapy in the last 21 days.

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I had a transplant from a donor less than 3 months ago.

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I had a stem cell or organ transplant less than 60 days ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nanatinostat with ValganciclovirExperimental Treatment1 Intervention

Patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week with valganciclovir 900 mg orally once daily. Up to 10 PTCL patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lymphoma include histone deacetylase inhibitors (HDACi) like Nanatinostat, which modify gene expression to inhibit cancer cell growth and induce apoptosis. Antivirals like Valganciclovir are used to target virus-associated lymphomas by inhibiting viral DNA synthesis. Additionally, chemotherapy, immunotherapy, and targeted therapies are frequently used. Chemotherapy kills rapidly dividing cells, immunotherapy boosts the immune system to fight cancer, and targeted therapies block specific molecules involved in cancer growth. Understanding these mechanisms helps tailor treatment to the patient's specific type of lymphoma, potentially improving outcomes and minimizing side effects.

Diagnosis-to-Treatment Interval Is an Important Clinical Factor in Newly Diagnosed Diffuse Large B-Cell Lymphoma and Has Implication for Bias in Clinical Trials.[Staging and Treatment Response Evaluation in Malignant Lymphomas - Czech Lymphoma Study Group Recommendations According to Criteria Revised in 2014 (Lugano Classification)].