Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas MedDRA version: 21.0 Level: PT Classification code 10071441 Term: Epstein-Barr virus associated lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Nanatinostat
Product Code: VRx-3996
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Nanatinostat
CAS Number: 1256448-47-1
Current Sponsor code: VRx-3996
Concentration unit:
Sponsors
Viracta Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients age =18 years or as permitted by applicable local regulations at the time of informed consent. Patients must be able to swallow whole tablets. a. For patients with PTLD: Age =12 years and weighing =40 kg 2. EBV+ relapsed/refractory lymphoma following 2 or more prior systemic therapies 3. Patients must have received at least one course of an anti-CD20 immunotherapy, and at least one course of anthracycline-based chemotherapy 4. Hodgkin lymphoma: Must have received at least one course of antracycline-based chemotherapy. Patients with classical Hodgkin lymphoma should have failed or be ineligible for an anti-PD-1 agent and CD30-directed therapy. 5. For patients with ENKTL: Relapsed/ refractory disease following 1 or more prior systemic therapies. Patients must have failed an a sparaginase-containing regimen. 6. For patients with PTCL (PTCL, NOS and AITL): relapsed or refractory disease following 1 or more prior systemic therapies with a curative intent. 7. For patients with PTLD: Patients with relapsed or refractory EBV+ PTLD who have received at least one prior therapy must have received at least one course of an antiCD20 immunotherapy such as rituximab. For solid-organ transplant (SOT) patients, prior therapy also includes chemotherapy, administered concurrently or sequentially, unless chemotherapy is inappropriate. 8. No available therapies in the opinion of the investigator. 9. Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T Therapy. 10. Measurable disease per Lugano 2007. 11. ECOG performance status 0, 1, 2. 12. Adequate bone marrow function. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 433 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
Exclusion criteria: 1. Presence or history of central nervous system (CNS) involvement by lymphoma. 2. Systemic anticancer therapy or CAR within 21 days. 3. Antibody (anticancer) agents within 28 days. 4. Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant. 5. Less than 90 days from prior allogeneic transplant. 6. Daily corticosteroids (=20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1. 7. Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir. 8. Active infection requiring systemic therapy (Excluding viral upper respiratory tract infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anti-tumor activity of the combination treatment of nanatinostat (Nstat) with valganciclovir (VGCV) based on objective tumor response rates ;Secondary Objective: To determine the duration of tumor control To determine survival outcomes To describe the safety profile of the combination treatment of Nstat with VGCV To generate pharmacokinetic (PK) data ;Primary end point(s): • Objective response rate (ORR) as assessed by an Independent Review Committee (IRC) per the 2007 International Working Group (IWG) criteria. ;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is ORR assessed by an IRC every 8 weeks until 24 weeks, and then every 12 weeks for the remainder of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Duration of response (DOR) • Time to next anti-lymphoma treatment • Progression-free survival • Time to progression • Overall survival (OS) • Pharmacokinetic (PK) parameters (eg, time to maximum plasma concentration [tmax], maximum plasma concentration [Cmax], area under the plasma concentration-time curve [AUC]). ;Timepoint(s) of evaluation of this end point: Overall survival,Time to next anti-lymphoma treatment, Duration of response, Progression free survival | — |
Countries
Australia, Brazil, Canada, France, Germany, Hong Kong, Israel, Italy, Korea, Republic of, Malaysia, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Viracta Therapeutics, Inc.
Outcome results
None listed