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Clinical Trials in China / NCT06255795
Starting soon Phase 3

The Efficacy and Safety of Chidamide, Anti-PD-1 Antibody in Combination With Pegaspargase Versus DDGP in the Treatment of Newly Diagnosed, Stage III to IV Extranodal Natural Killer/T-Cell Lymphoma

NCT06255795 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Phase 3
Started
2024-02-15
Last updated
2024-02-13

Condition(s) studied

Extranodal Natural Killer T Cell Lymphoma

Investigational drug(s) / intervention(s)

chidamide, anti-PD1 antibody, and pegaspargaseDDGP

chidamide, anti-PD1 antibody, and pegaspargase: 6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, anti-PD1 antibody 200mg intravenously on day 2, chidamide 30mg biw orally, every 21 days.

DDGP: 6 cycles of pegaspargase 2500IU/m2 intramuscularly on day1, cisplatin 20mg/m2 intravenously on days 1 through 4, dexamethasone 15mg/m2 intravenously on days 1 through 5, gemcitabine 800mg/m2 on day 1 and day 8, every 21 days.

Study summary

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of chidamide, anti-PD1 antibody, and pegaspargase versus dexamethasone, cisplatin, gemcitabine, and pegaspargase (DDGP) in the treatment of newly diagnosed, stage III to IV extranodal natural killer/T-cell lymphoma.

Eligibility

Sex
ALL
Min age
14 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Confirmed histological diagnosis of NKTCL * No previous anti-lymphoma treatment * Age 14-70 years * Ann Arbor stage III-IV * At least one measurable/evaluable site after diagnostic biopsy before treatment start * ECOG performance status of 0-2 * Adequate hematological and organ function; i.e. ANC \>1000 cells /mmc, platelet counts \> 50.000/mmc, Hemoglobin \> 8 g/dl AST, ALT \> 1.5 x ULN; serum bilirubin \> 2x ULN (patient with Gilbert disease can be enrolled), Serum creatinine \> 2 x ULN or creatinine clearance \> 50ml/min * Tumor tissue (fresh preferred, achievable tissue is also acceptable) * For women of childbearing potential a negative pregnancy test on day 1 of cycle 1 and agree to adopt adequate measure to avoid pregnancy during study treatment and for at least one year from EOT. * For men agreement to remain abstinent or to use barrier contraception * Signed Informed consent Exclusion Criteria: * Confirmed histological diagnosis of aggressive NK cell leukemia * Early stage disease (AA stage I-II) * 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 myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associate with antiphospholipid syndrome, wegener's granulomatosis, Sjogren syndrome, guillan barreè 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. * Active infection requiring systemic therapy * History of (non-infectious) pneumonitis that required steroids; evidence of interstitial lung disease or active, non-infectious pneumonitis * Significant cardiovascular disease, myocardial infarction in the previous 3 months, unstable arrhythmias, or unstable angina. * History of other(s) infiltrating cancer(s) in the previous 3 years that were not treated with curative intent or who are still receiving anticancer therapy (including hormone therapy for breast or prostate cancer). * HBsAg, HCV or HIV positivity. Positive serology is admitted for HBV and HCV but DNA/RNA test must be negative * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent * Pregnant or lactating women * Administration of a live attenuated vaccine within 4 weeks before cyle 1 day 1. Patients must not receive live, attenuate vaccines, including influenza vaccines at any time during study. * Other uncontrollable medical condition that may that may interfere the participation of the study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06255795 on ClinicalTrials.gov ↗ ← All trials in China