An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Re… (NCT05011058) | Clinical Trial Compass
TerminatedPhase 2
An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas
Stopped: Sponsor Decision
United States102 participantsStarted 2021-05-28
Plain-language summary
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key 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
Key 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 n…