Selinexor, Anti-PD-1 Antibody Plus Golidocitinib in R/R NKTCL
- Conditions
- Lymphoma, Extranodal NK-T-Cell
- Registration Number
- NCT06573138
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Confirmed histological diagnosis of NKTCL nasal type<br><br> 2. The subject had received prior adequate anti-lymphoma therapy containing<br> asparaginase<br><br> 3. Age 14-75 years old<br><br> 4. expected to live longer than 3 months<br><br> 5. At least one measurable/evaluable site after diagnostic biopsy before treatment<br> start<br><br> 6. ECOG performance status of 0-2<br><br> 7. Adequate hematological and organ function; i.e. ANC >1000 cells /mmc, platelet<br> counts > 50.000/mmc, Hemoglobin > 9 g/dl AST, ALT <3 x ULN; serum bilirubin < 1.5x<br> ULN (patient with Gilbert disease can be enrolled)Serum creatinine < 2 x ULN or<br> creatinine clearance > 50ml/min<br><br> 8. Tumor tissue (fresh preferred, archival tissue is also acceptable)<br><br> 9. For women of childbearing potential a negative pregnancy test on day 1 of cycle 1<br> and agree to adopt adequate measure to avoid pregnancy during study treatment and<br> for at least one year from EOT.<br><br> 10. For men agreement to remain abstinent or to use barrier contraception<br><br> 11. Signed Informed consent<br><br>Exclusion Criteria:<br><br> 1. Confirmed histological diagnosis of aggressive NK cell leukemia<br><br> 2. Evidence of suspect of CNS disease.<br><br> 3. Has an active autoimmune disease that has required systemic treatment in past<br> 2-years (ie, with use of disease modifying agents, corticosteroids or<br> immunosuppressive drugs), including but not limited to myotonia gravis, myositis,<br> autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,<br> inflammatory bowel disease, vascular thrombosis associate with antiphospholipid<br> syndrome, wegener's granulomatosis, Sjogren syndrome, Guillain-Barre syndrome,<br> multiple sclerosis, vasculitis or glomerulonephritis. The following exception are<br> allowed: patients with autoimmune related hypothyroidism or type I diabetes mellitus<br> who are on stable treatment. Replacement therapy (eg, thyroxine, insulin, or<br> physiologic corticosteroid replacement therapy for adrenal or pituitary<br> insufficiency) is not considered a form of systemic treatment and is allowed.<br><br> 4. Treatment with systemic immunosuppressive medications, including prednisone,<br> cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-tumor necrosis<br> factor (anti-TNF) agents within 2 weeks prior to cycle 1 day 1; inhaled<br> corticosteroids are allowed.<br><br> 5. Active infection requiring systemic therapy<br><br> 6. History of (non-infectious) pneumonitis that required steroids; evidence of<br> interstitial lung disease or active, non-infectious pneumonitis<br><br> 7. Significant cardiovascular disease, myocardial infarction in the previous 3 months,<br> unstable arrhythmias, or unstable angina.<br><br> 8. History of other(s) infiltrating cancer(s) in the previous 3 years that were not<br> treated with curative intent or who are still receiving anticancer therapy<br> (including hormone therapy for breast or prostate cancer).<br><br> 9. HBsAg, HCV or HIV positivity. Positive serology is admitted for HBV and HCV but<br> DNA/RNA test must be negative<br><br> 10. Pregnant or lactating women<br><br> 11. Administration of a live attenuated vaccine within 4 weeks before cyle 1 day 1.<br> Patients must not receive live, attenuate vaccines, including influenza vaccines at<br> any time during study.<br><br> 12. Other uncontrollable medical condition that may interfere the participation of the<br> study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best CRR
- Secondary Outcome Measures
Name Time Method