An Open-Label, Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas (NAVAL-1) - NAVAL-1

Viracta Therapeutics, Inc.0 个研究点目标入组 150 人开始时间: 2021年6月9日最近更新: 2024年7月8日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Viracta Therapeutics, Inc.
入组人数: 150

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Adult patients age =18 years at the time of informed consent.
•2. Histologically confirmed (by 2016 WHO classification) EBV+ lymphoma* per local laboratory by EBER-ISH (or for PTLD only, by LMP-1 immunohistochemistry) on a representative disease specimen. Any degree of EBER-ISH or LMP-1 positivity is considered to be eligible (ie, there is no cut-off value for % positive cells).
•* Tumor cells are EBV+, with the exception of AITL, which is characterized by EBV-negative neoplastic T cells and EBV+ associated B-lineage cells (of immunoblastic/plasmablastic immunophenotype)
•a. A recent FFPE specimen must be available for central review. The specifications for the age of the tumor samples are:
•For patients with ENKTL, AITL, PTLD and HIV-L: preferably =1 year old. For tumor specimens >1 year old, please consult the Medical Monitor to discuss eligibility.
•For patients with all other lymphoma subtypes: preferably =6 months old. For tumor specimens >6 months old, please consult the Medical Monitor to discuss eligibility.
•3. For ENKTL patients only: Relapsed or refractory* disease following 1 or more prior systemic therapies with a curative intent. Patients must have failed an asparaginase-containing regimen.
•4. For non-ENKTL patients only: Relapsed or refractory* disease following 2 or more prior systemic therapies with a curative intent, with the following specifications:
•a. For EBV+ DLBCL, NOS: Patients must have received at least one course of an anti CD20 immunotherapy such as rituximab, and at least one course of anthracycline-based chemotherapy (unless contraindicated due to cardiac dysfunction, in which case, an accepted anthracycline-free alternative for DLBCL was given).
•b. For PTLD: Patients must have received immunotherapy with an anti-CD20 agent.
•c. For HL: Patients must have received at least one course of anthracycline-based chemotherapy (unless contraindicated due to cardiac dysfunction).
•*Patients are considered to have refractory disease if they had no response (ie, no CR or PR), or a response lasting <6 months to a prior systemic therapy.
•5. Patients with the following lymphomas associated with HIV infection (HIV-L): plasmablastic, Burkitt, Hodgkin lymphoma and DLBCL.
•6. Patients with HIV-L should meet defined criteria for inclusion
•7. No available standard therapies in the opinion of the Investigator.
•8. Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy at the time of study entry.
•9. Presence of at least one bi-dimensionally measurable lesion by CT or MRI: longest diameter (LDi) >1.5 cm for a nodal lesion; LDi >1.0 cm for an extranodal lesion within 28 days prior to start of treatment.
•10. Able to provide a core or excisional lymph node biopsy for biomarker analysis from an archival biopsy at screening.
•11. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
•12. All acute toxic effects of any prior anti-tumor therapy resolved to Grade =1 before initiation of study treatment (excluding alopecia and stable Grade 2 sensory neuropathy).
•13. Required baseline laboratory data (within 2 weeks prior to start of study drug administration) as shown in the protocol
•14. Life expectancy >3 months.
•15. Women of childbearing potential (ie, reached menarche, and not post-menopausal [(no menses for 12 months without an alternative medical cause) or surgically sterile]) must have the following:
•a. Understand that the study medication is expected to have terat

排除标准

•1. Presence or history of central nervous system (CNS) involvement by lymphoma.
•2. Systemic anticancer therapy within 21 days prior to Cycle 1 Day 1 dosing.
•3. Antibody (anticancer) agents within 28 days of Cycle 1 Day 1 dosing.
•4. Less than 14 days from prior local site radiation therapy.
•5. Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant.
•6. Less than 21 days from prior CAR-T therapy (any AEs must be grade 1 or less for enrollment).
•7. Less than 90 days from prior allogeneic transplant.
•8. Receiving systemic corticosteroids during the last week prior to Cycle 1 Day 1, unless administered at a dose equivalent to =20 mg/day of prednisone.
•9. For recipients of prior allogeneic HSCT: Receiving systemic immunosuppressants as either prophylaxis or treatment for GVHD.
•10. Major surgery within 28 days within the first dose of study drug. In case of recent major surgery, the patient must have recovered adequately from the procedure and/or any complications prior to starting study treatment.
•Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment.
•11. Is currently participating in or has participated in an interventional study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
•Note: Individuals who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks since the last dose of the previous investigational agent.
•12. History of previously treated cancer except for the following:
•a. Adequately treated:
•- local basal cell or squamous cell carcinoma of the skin, or related localized non melanoma skin cancer.
•- cervical carcinoma in situ.
•- superficial bladder cancer.
•- localized prostate cancer undergoing surveillance or previously fully resected.
•- localized breast cancer treated with surgery and/or radiotherapy and/or endocrine therapy, but not including systemic chemotherapy.
•- other adequately treated Stage 1 or 2 cancer currently in complete remission.
•13. Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.
•14. Active graft-versus-host disease (GvHD).
•15. Positive hepatitis B core antibody or surface antigen unless quantitative DNA polymerase chain reaction (PCR) is negative, and patient will be receiving prophylaxis for reactivation.
•16. Positive hepatitis C virus on RNA PCR.
•17. Known SARS-CoV-2 positivity.
•18. History of allergic reactions attributed to compounds of similar chemical or biologic composition to valganciclovir or nanatinostat.
•19. Active infection requiring systemic therapy (excluding viral upper respiratory tract infections). Patients may be receiving prophylactic antiviral, antifungal or antibacterial therapies at the discretion of the Investigator.
•20. Prolongation of corrected QT interval using Fridericia’s formula (QTcF) to >480 msec, requires the coadministration of drugs known to prolong QT (Class Ia [disopyramide, quinidine, procainamide] and Class III [sotalol, dofetilide, ibutilide] antiarrhythmic agents), and/or has a history of Torsades de Pointes (TdP).
•21. Receiving concomitant drugs that are inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP; unless they can be held for 2 weeks

研究者

发起方

Viracta Therapeutics, Inc.

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