Clinical trial · Interventional
PEG-ASP+Gemox Regimen and Thalidomide for NK/T Lymphoma
PA-Gemox Regimen Followed by Thalidomide Versus AspaMetDex Regimen in NKTCL Patients：a Randomized, Open-label, Phase 3 Study
NCT02085655CI-TRIAL-00050650unknownPhase 3ClinicalTrials.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)
Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the efficacy and safety of long-acting aspargase (pegylated aspargase, PEG-ASP) combined with gemcitabine and oxaliplatin (PASP -Gemox) treatment in this population.
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 and Nasal-Type | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| pegaspargase | Drug | Pegaspargase | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PEG-ASP+Gemox regimen group
- description
- PEG-ASP 2000U/m2 im d1 Gemcitabine 800mg/m2 ivdrip 30min d1，8 Oxaliplatin 100mg/m2 ivdrip d1 Thalidomide 150-200mg po qn d8-21
- interventionNames
- Drug: pegaspargase
- Drug: Gemcitabine
- Drug: Oxaliplatin
- Drug: Thalidomide
- type
- ACTIVE_COMPARATOR
- label
- AspaMetDex regimen group
- description
- Pegaspargase 2000U/m2 im， d1 methotrexate 3000m g/m2 civ 6-hour，d1, Calcium folinate 30mg iv q6h x6 Dexamethasone 40 mg ivdrip QD
- interventionNames
- Drug: pegaspargase
- Drug: Methotrexate
- Drug: Dexamethasone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification; 2. age≥18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 4. at least one measurable lesion; 5. adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l), 6. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), 7. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); 8. normal coagulation function and electrocardiogram results. 9. Prior chemotherapy and radiotherapy should have been completed \>4 weeks earlier, 10. willingness to provide written informed consent. Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.