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An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

PHASE2RECRUITING

A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas.

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Study details:

Patients with EBV-associated lymphomas have inferior outcomes with standard-of-care therapies compared to those with EBV-negative disease. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. This open-label, multicenter, multinational, single-arm, Phase 2 basket study employs a Simon's 2-stage design to allow termination of enrollment into cohorts where treatment appears futile, and will include the following cohorts of patients with EBV+ relapsed/refractory lymphomas:.

1. EBV+ diffuse large B-cell lymphoma (DLBCL, NOS). 2.

Peripheral T-cell lymphoma (PTCL), including PTCL-NOS and AITL. 3. Post-transplant lymphoproliferative disorder (PTLD).

4. EBV+ lymphoproliferative disorders other than the above, including Extranodal NK/T-cell lymphoma (ENKTL).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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 criteria

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).

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-05-28

Primary completion: 2025-07-01

Study completion finish: 2026-12-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05011058

Intervention or treatment

DRUG: Nanatinostat in combination with valganciclovir

Conditions

• Epstein-Barr Virus Associated Lymphoproliferative Disorder
• EBV-Related PTLD
• EBV Related Non-Hodgkin's Lymphoma
• EBV-Positive DLBCL, NOS
• EBV Associated Lymphoma
• EBV Related PTCL, NOS

Image related to Epstein-Barr Virus Associated Lymphoproliferative Disorder

Condition: Epstein-Barr Virus Associated Lymphoproliferative Disorder, EBV-Related PTLD and more
DRUG: Nanatinostat in combination with valganciclovir
Melbourne, Victoria, Australia and more
Sponsor: Viracta Therapeutics, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The Alfred Hospital

Research sites nearby

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The Alfred Hospital
Melbourne, Victoria, Australia
Box Hill Hospital
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Nanatinostat with Valganciclovir 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.	DRUG: Nanatinostat in combination with valganciclovir Drug: Nanatinostat, 20 mg orally once daily, 4 days per week in 28 day cycles Other name: VRx-3996 Drug: Valganciclovir, 900 mg orally once daily in 28 day cycles

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Objective response rate (ORR)	Assessed by an Independent Review Committee (IRC) per the 2007 International Working Group Response Criteria (IWGRC)	Approximately 3 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Duration of response (DOR)	Not Specified	Approximately 3 years
Time to next anti-lymphoma treatment (TTNLT)	Not Specified	Approximately 3 years
Progression-free survival (PFS)	Not Specified	Approximately 3 years
Time to progression (TTP)	Not Specified	Approximately 3 years
Overall survival	Not Specified	Approximately 3 years
Incidence and severity of treatment-emergent adverse events	Not Specified	Approximately 28 days following the last dose
Pharmacokinetic parameter - time to maximum plasma concentration [tmax],	Not Specified	Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days)
Pharmacokinetic parameter - maximum plasma concentration [Cmax]	Not Specified	Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days)
Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC]	Not Specified	Approximately 6 months following the end of Cycle 1 Day 1 (each cycle is 28 days)

Frequently Asked Questions

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References

Clinical Trials Gov: An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas