An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 Years and older, Male and Female
VT3996-202 (primary)
NCI-2021-09770
Summary
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with
valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Objectives
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)
Eligibility
- 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 Key
Treatment Sites in Georgia
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