Neoplasms

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Lymphoma, Large B-Cell, Diffuse

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Anti-Infective Agents

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Valganciclovir

Antiviral Agents

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, 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

Nanatinostat in combination with valganciclovir

Strait Hicklin

Donald (D.K.) Strickland, MD

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

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)

This is an open-label, single-arm study utilizing a basket trial design.

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

Assessed by an Independent Review Committee (IRC) per the 2007 International Working Group Response Criteria (IWGRC)

Viracta Therapeutics, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas	NCT05011058	Epstein-Barr Vi... EBV-Related PTL... EBV Related Non... EBV-Positive DL... EBV Associated ... EBV Related PTC...	Nanatinostat in...	18 Years -	Viracta Therapeutics, Inc.
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas	NCT05011058	Epstein-Barr Vi... EBV-Related PTL... EBV Related Non... EBV-Positive DL... EBV Associated ... EBV Related PTC...	Nanatinostat in...	18 Years -	Viracta Therapeutics, Inc.

Spots Global Cancer Trial Database for ebv positive t cell lymphoma