NK-T-Cell Lymphoma, ExtranodalPhase 3NCT06953739
A Study Comparing of P-GEMD Regimen Versus P-Gemox Regimen With Untreated Early-Stage NUAT or Advanced-Stage ENKTL.
A Phase 3 study testing P-GEMD and P-Gemox in people with NK-T-Cell Lymphoma, Extranodal, run by The First Affiliated Hospital with Nanjing Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NK-T-Cell Lymphoma, Extranodal
- What is being tested?
- P-GEMD and P-Gemox
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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).
Who cannot join
- 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 : 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.
- 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; 9.Other investigators judge that they are not suitable for participating in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jinhua Liang contact
About this study
Official title: A Multicenter, Randomized Controlled Clinical Study of Pegaspargase Combined With P-GEMD Regimen Versus P-Gemox Regimen in the Treatment of Untreated Early-Stage Non-Upper Aerodigestive Tract or Advanced-Stage Extranodal NK/T-Cell Lymphoma.
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.
Read the detailed description
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.
- Conditions
- NK-T-Cell Lymphoma, Extranodal
- Being tested
- P-GEMD, P-Gemox
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-GEMDDrug
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-GemoxDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: P-Gemox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
Response is assessed according to the lugano criteria.
Measured: 5.5years
Secondary outcomes (6)
Overall Response Rate (ORR)
Response is assessed according to the lugano criteria.
Measured: 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.
Measured: 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.
Measured: 5.5years
Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause.
Measured: 5.5years
EBV-DNA load level (before and after treatment)
EBV-DNA was detected at time points before and after treatment.
Measured: 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.
Measured: From the first day of medication to 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NK-T-Cell Lymphoma, ExtranodalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Xu, Principal investigator, he First Affiliated Hospital with Nanjing Medical University, Nanjing, ChinaJinhua Liang, Principal investigator, he First Affiliated Hospital with Nanjing Medical University, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953739
- Sponsor's protocol ID
- CSPC-DED-NKTCL-K05
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Clinical Study of Pegaspargase Combined With P-GEMD Regimen Versus P-Gemox Regimen in the Treatment of Untreated Early-Stage Non-Upper Aerodigestive Tract or Advanced-Stage Extranodal NK/T-Cell Lymphoma.
- ClinicalTrials.gov ID
- NCT06953739
- Acronym / sponsor ID
- CSPC-DED-NKTCL-K05
- Conditions
- NK-T-Cell Lymphoma, Extranodal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P-GEMD | Experimental | Drug: P-GEMDThe 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. |
| P-Gemox | Other | Drug: P-GemoxThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. 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).
Key exclusion criteria (2 listed)
- 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 : 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.
- 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; 9.Other investigators judge that they are not suitable for participating in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-GEMDDrug: 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 | P-GEMD |
| P-GemoxDrug: 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. | Drug | P-Gemox |
Primary outcome
Complete Response (CR) Rate
Time frame: 5.5years
Response is assessed according to the lugano criteria.
6 secondary outcomes
Overall Response Rate (ORR)
Time frame: 5.5years
Progression-Free-Survival (PFS)
Time frame: 5.5years
Duration of Response (DOR)
Time frame: 5.5years
Overall survival (OS)
Time frame: 5.5years
EBV-DNA load level (before and after treatment)
Time frame: 5.5 years
Hematologic and non-hematologic toxicity.
Time frame: From the first day of medication to 28 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinhua Liang contact
Wei Xu principal investigator
he First Affiliated Hospital with Nanjing Medical University, Nanjing, China
Jinhua Liang principal investigator
he First Affiliated Hospital with Nanjing Medical University, Nanjing, China
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing P-GEMD and P-Gemox in people with NK-T-Cell Lymphoma, Extranodal, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Xu (8613951699449, xuwei10000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate (time frame: 5.5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.