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NK/T-cell lymphoma (NKTCL) is one of the most common types of extranodal lymphoma.NKTCL originates from NK cells and T lymphocytes and is highly invasive. There is a lack of efficient and specific treatment methods in clinical practice, and the prognosis is poor. The molecular heterogeneity of NKTCL is strong, and molecular typing and risk stratification are of great significance for understanding the disease and improving the curative effect.Based on the preclinical studies of mitoxantrone liposomes, the investigators put forward a hypothesis: mitoxantrone liposome injection combined with pegaspargase, gemcitabine, and dexamethasone (P-GEMD) in the treatment of early non-upper respiratory digestive tract It is safe and can improve the therapeutic effect in patients with gastric or advanced extranodal NK/T cell lymphoma.
Full description
NK/T-cell lymphoma (NKTCL) is one of the most common types of extranodal lymphoma.NKTCL originates from NK cells and T lymphocytes and is highly invasive. There is a lack of efficient and specific treatment methods in clinical practice, and the prognosis is poor. The molecular heterogeneity of NKTCL is strong, and molecular typing and risk stratification are of great significance for understanding the disease and improving the curative effect.
In the phase II clinical study of mitoxantrone liposome, 108 patients with relapsed and refractory PTCL received mitoxantrone liposome monotherapy, and the IRC evaluation ORR was 41.7% [32.3%, 51.5%] , the CR rate was 23.1% (25/108), the median PFS was 8.5 months, and the median OS was 22.8 months. The safety was tolerable and the efficacy was definite. Based on this, Mitoxantrone liposome was approved for marketing , for the treatment of adult patients with relapsed and refractory PTCL.
Based on the preclinical studies of mitoxantrone liposomes, the investigators put forward a hypothesis: mitoxantrone liposome injection combined with pegaspargase, gemcitabine, and dexamethasone (P-GEMD) in the treatment of early non-upper respiratory digestive tract It is safe and can improve the therapeutic effect in patients with gastric or advanced extranodal NK/T cell lymphoma.
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Hypersensitivity to any study drug or its components; 2. Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); 3. Cardiac function and disease meet one of the following conditions :
long QTc syndrome or QTc interval >480 ms;
complete left bundle branch block, second-degree or third-degree atrioventricular block;
severe, uncontrolled arrhythmia requiring drug treatment ;
New York Society of Cardiology ≥ Grade III;
Cardiac ejection fraction (LVEF) lower than 50%;
Myocardial infarction, unstable angina, and severely unstable ventricular rhythm within 6 months before recruitment History of arrhythmia or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities.
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50 participants in 1 patient group
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Wei XU, Doctor
Data sourced from clinicaltrials.gov
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