Clinical trial · Interventional
GPED Regimen for Relapsed/Refractory or Advanced ENKTCL
Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study
NCT04405375CI-TRIAL-00045298unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK/T-cell Lymphoma, Nasal Type | Extranodal NK-/T-Cell Lymphoma, Nasal Type | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| gemcitabin | Drug | — | UNRESOLVED |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- description
- gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =\<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
- interventionNames
- Drug: gemcitabin
- Drug: Pegaspargase
- Drug: Etoposide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- 2-year progression free survival (PFS) rate
- timeFrame
- From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
- description
- PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria. * refractory or relapsed after initial remission, or stage III-IV de novo patients * PET/CT or CT/MRI with at least one objectively evaluable lesion. * General status ECOG score 0-3 points. * The laboratory test within 1 week before enrollment meets the following conditions: * Blood routine: Hb\>80g/L, PLT\>50×10e9/L. * Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. * Renal function: Cr is normal. * Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking. * Sign the informed consent form Exclusion Criteria: * Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded. * Significant organ dysfunction Pregnant and lactating women. * Those who were known to be allergic to drugs in the study regimen. * Patients with other tumors who require surgery or chemotherapy within 6 months. * Other experimental drugs are being used.
References
Publications (0)
Data not yet available
No reference posted for this study.