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Trial Title:
Pegaspargase Combined With Gemcitabine, Etoposide, Liposomal Mitoxantrone Hydrochloride and Dexamethasone (P-GEMD) in the Treatment of Untreated Early Non-upper Respiratory Tract or Advanced Extranodal NK/T-cell Lymphoma
NCT ID:
NCT05774028
Condition:
NK-T-Cell Lymphoma, Extranodal
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Extranodal NK-T-Cell
Dexamethasone
Gemcitabine
Etoposide
Mitoxantrone
Pegaspargase
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pegaspargase Combined With Gemcitabine, Etoposide, Liposomal Mitoxantrone Hydrochloride and Dexamethasone (P-GEMD) regimen
Description:
P-GEMD regimen (Every 3 weeks as a cycle, a total of 6 cycles) : Pegaspargase 3750 IU,
d2; Gemcitabine 1000mg/m2, d1; Etoposide 65mg/m2, d2-d4; Mitoxantrone hydrochloride
liposome 12mg/m2, d1; Dexamethasone 40mg/d, d1- d4.
Arm group label:
P-GEMD group
Summary:
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Voluntarily join this study and sign the informed consent form; 2. 18 years old
≤ age ≤ 75 years old; 3. Expected survival time ≥ 3 months; 4.
Histopathologically confirmed early non-upper aerodigestive or advanced 5.
There must be at least one evaluable or measurable lesion that meets the
Lugano2014 criteria: lymph node lesions, measurable lymph nodes need to have a
long diameter > 1.5cm; non-lymph node lesions, extranodal lesions that can be
measured Long diameter > 1.0cm; 6. ECOG score 0-2 points; 7. Bone marrow
function: neutrophil count ≥ 1.5×109/L, platelet count ≥ 75×109/L, hemoglobin ≥
80g/L; 8. Liver and kidney function: serum creatinine ≤ 1.5 times the upper
limit of the normal value; alanine aminotransferase (AST) and aspartate
aminotransferase (ALT) ≤ 2.5 times the upper limit of the normal value (for
patients with liver invasion ≤ 5 times the normal value upper limit); total
bilirubin ≤ 1.5 times the upper limit of normal value (for patients with liver
invasion ≤ 3 times the upper limit of normal value).
Exclusion Criteria:
-
1. 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 :
1. long QTc syndrome or QTc interval >480 ms;
2. complete left bundle branch block, second-degree or third-degree
atrioventricular block;
3. severe, uncontrolled arrhythmia requiring drug treatment ;
4. New York Society of Cardiology ≥ Grade III;
5. Cardiac ejection fraction (LVEF) lower than 50%;
6. 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.
4. Active hepatitis B and C infection (positive hepatitis B virus surface
antigen and more than 1x103 copies/mL of hepatitis B virus DNA; more than
1x103 copies/mL of hepatitis C virus RNA); 5. Human immunodeficiency virus
(HIV) infection (positive HIV antibody); 6. Previously or currently
suffering from other malignant tumors (except for effectively controlled
non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ
and other malignant tumors that have been effectively controlled without
treatment in the past five years); 7. Central nervous system (CNS)
involvement at the time of recruitment; 8. Pregnant, lactating women and
patients of childbearing age who do not want to take contraceptive
measures; Other investigators judge that they are not suitable for
participating in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 2023
Completion date:
April 2025
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05774028
