A Study Comparing of P-GEMD Regimen Versus P-Gemox Regimen With Untreated Early-Stage NUAT or Advanced-Stage ENKTL.

NCT06953739 | Not Yet Recruiting Phase 3

• 1 other identifier: CSPC-DED-NKTCL-K05
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

NK-T-Cell Lymphoma, Extranodal

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) Rate

  Response is assessed according to the lugano criteria.

  5.5years

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  5.5years

• Progression-Free-Survival (PFS)

  5.5years

• Duration of Response (DOR)

  5.5years

• Overall survival (OS)

  5.5years

• EBV-DNA load level (before and after treatment)

  5.5 years

Study Arms (2)

P-GEMD

EXPERIMENTAL

The P-GEMD regimen (pegaspargase at 3750 IU, d2; gemcitabine at 1000 mg/m2, d1; etoposide at 65 mg/m2, d2-4; mitoxantrone hydrochloride liposome at 12mg/m2, d1; dexamethasone at 40 mg/d, d1-4.) was administered intravenously every 3 weeks until up to 6 cycles of planned therapy.

Drug: P-GEMD

P-Gemox

OTHER

The P-Gemox regimen (pegaspargase at 2000-2500 IU/m2, d2; gemcitabine at 1000 mg/m2, d1, d8; oxaliplatin at 130 mg/m2, d1) was administered intravenously every 3 weeks until up to 6 cycles of planned therapy.

Drug: P-Gemox

Interventions

P-GEMD DRUG

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.

P-GEMD

P-Gemox DRUG

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.

P-Gemox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily join this study and sign the informed consent form; 2.Age ≥18 years old; 3.Expected survival time ≥ 3 months; 4. Histopathologically confirmed early non-upper aerodigestive or advanced ENKTL; 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(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×109/L, Platelet count (PLT) ≥50×109/L, Hemoglobin(HB)≥ 75g/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).

You may not qualify if:

• 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 : A.long QTc syndrome or QTc interval \>480 ms; B.complete left bundle branch block, second-degree or third-degree atrioventricular block; C.severe, uncontrolled arrhythmia requiring drug treatment ; D.New York Society of Cardiology ≥ Grade III; E.Cardiac ejection fraction (LVEF) lower than 50%; F.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.
• \. 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; 9.Other investigators judge that they are not suitable for participating in this study.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Wei Xu

  he First Affiliated Hospital with Nanjing Medical University, Nanjing, China

  PRINCIPAL INVESTIGATOR

• Jinhua Liang

  he First Affiliated Hospital with Nanjing Medical University, Nanjing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xu

CONTACT

8613951699449; xuwei10000@hotmail.com

Jinhua Liang

CONTACT

1151525490@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 1, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share