EUCTR2020-005197-10-IT进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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.
- •For full list please refer to Protocol or Synopisis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
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.
- •For full list please refer to Protocol or Synopisis
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