| Titre |
An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas |
| Protocole ID |
VT3996-202 |
| ClinicalTrials.gov ID |
NCT05011058 |
| Type(s) de cancer |
Lymphome non-hodgkinien (LNH) |
| Phase |
Phase II |
| Stade |
Récidivant/réfractaire (2ième ligne de traitement et plus) |
| Type étude |
Clinique |
| Médicament |
Nanatinostat en association avec le Valganciclovir |
| Institution |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
 PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX
5415 boul. de l'Assomption, Montréal, QC, H1T2M4
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Isabelle Fleury
|
| Coordonnateur(trice) |
Julie Trinh Lu
514-252-3400 poste 3336
|
| Statut |
 Actif en recrutement |
| Date d'activation |
06-01-2022 |
| Critètes d'éligibilité |
- EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies
- EBV+ DLBCL, NOS: Must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy
- PTLD: Must have received immunotherapy with an anti-CD20 agent.
- Hodgkin lymphoma: Must have received at least one course of anthracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy.
- For extranodal NK/T-cell lymphoma patients only: Relapsed/refractory disease following 1 or more prior systemic therapies. Patients must have failed an asparaginase-containing regimen.
- 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 Lugano 2007
- ECOG performance status 0, 1, 2
- Adequate bone marrow function
|
| Critètes d'exclusion |
- 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).
|
Groupe d'étude en oncologie du Québec