Selinexor, Anti-PD-1 Antibody Plus Golidocitinib in R/R NKTCL

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-75
SponsorRuijin Hospital

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

Treatment groups

18 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators