About this trial
A multicenter, prospective trial to evaluate the efficacy and safety of Selinexor, anti-PD-1 antibody plus Golidocitinib in the treatment of relapsed or refractory Natural Killer / T-cell lymphoma.
Eligibility criteria
Qualifiers
Confirmed histological diagnosis of NKTCL nasal type
The subject had received prior adequate anti-lymphoma therapy containing asparaginase
Age 14-75 years old
expected to live longer than 3 months
Disqualifiers
Confirmed histological diagnosis of aggressive NK cell leukemia
Evidence of suspect of CNS disease.
Has an active autoimmune disease that has required systemic treatment in past 2-years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs), including but not limited to myotonia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associate with antiphospholipid syndrome, wegener's granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis. The following exception are allowed: patients with autoimmune related hypothyroidism or type I diabetes mellitus who are on stable treatment. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
Treatment with systemic immunosuppressive medications, including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor (anti-TNF) agents within 2 weeks prior to cycle 1 day 1; inhaled corticosteroids are allowed.
Trial design
Treatments tested in this trial
- Selinexor, anti-PD-1 antibody plus Golidocitinib