Extranodal natural-killer (NK)/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin lymphoma with a poor prognosis. Notably, patients with advanced-stage disease or early-stage non-upper aero-digestive tract (NUAT) involvement frequently develop hemophagocytic lymphohistiocytosis (HLH), necessitating more effective therapeutic interventions. This Multicenter, Randomized Controlled Clinical Study aimed to compare the efficacy and safety of P-GEMD and P-Gemox in the treatment of newly diagnosed early NUAT or advanced-stage ENKTL.
This Multicenter, Randomized Controlled Clinical Study aimed to compare the efficacy and safety of P-GEMD and P-Gemox in the treatment of newly diagnosed early NUAT or advanced-stage ENKTL. The P-GEMD regimen (pegaspargase; gemcitabine; etoposide; mitoxantrone hydrochlorid liposome; dexamethasone) was administered intravenously every 3 weeks until up to 6 cycles of planned therapy. The P-Gemox regimen ( Pegaspargase, Gemcitabine, and Oxaliplatin) was administered intravenously 3 weeks until up to 6 cycles of planned therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (12 mg/m2) on day 1, every 3 weeks; Drug: Pegaspargase Pegaspargase(3750 IU) on day 2, every 3 weeks; Drug: Gemcitabine Gemcitabine (1000 mg/m2) on day 1, every 3 weeks; Drug: Etoposide Etoposide (65 mg/m2) on day 2-4, every 3 weeks. Drug: Dexamethasone Dexamethasone (40 mg/d) will be taken orally from day 1-4, every 3 weeks; Patients \> 65 years of age may be adjusted according to the investigator's decision.
Drug: Pegaspargase Pegaspargase(2000-2500 IU/m2) on day 1, every 3 weeks; Drug: Gemcitabine Gemcitabine (1000 mg/m2) on day 1 and day 8, every 3 weeks; Drug: Oxaliplatin Oxaliplatin (130mg/m2) on day 1, every 3 weeks; Patients \> 65 years of age may be adjusted according to the investigator's decision.
Complete Response (CR) Rate
Response is assessed according to the lugano criteria.
Time frame: 5.5years
Overall Response Rate (ORR)
Response is assessed according to the lugano criteria.
Time frame: 5.5years
Progression-Free-Survival (PFS)
From the time subjects were enrolled to the time of disease progression (in any way) or death from any cause.
Time frame: 5.5years
Duration of Response (DOR)
The time between meeting the criteria for treatment effectiveness (first recorded complete or partial response) and the first clear recurrence or progression.
Time frame: 5.5years
Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause.
Time frame: 5.5years
EBV-DNA load level (before and after treatment)
EBV-DNA was detected at time points before and after treatment.
Time frame: 5.5 years
Hematologic and non-hematologic toxicity.
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.Hematologic and non-hematologic toxicity.
Time frame: From the first day of medication to 28 days after the last dose
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