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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Selinexor, anti-PD-1 antibody plus Golidocitinib
DrugSelinexor, 40mg, qw, po; anti-PD1 antibody, 200mg, d1, i.v. (21d cycle); Golidocitinib, Dose 1, 150mg, qod, po; Dose2, 150mg, qd, po.
Treatment groups
Trial outcomes
Primary outcomes
Best CRR
CRR defined according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: