Clinical trial · Interventional
Pegaspargase and Methotrexate Based Regimens for Newly Diagnosed Extranodal NK/T Cell Lymphoma
NCT02825147CI-TRIAL-00030360completedPhase 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)
Extranodal NK/T cell lymphoma is an aggressive tumor with higher incidence in Asia.Traditional CHOP/CHOP-like regiment can't produce satisfied outcome for the patients. Asparaginase-based treatment has been demonstrated as promising response rate and survival superiority. Stage-specified regimen may bring out exciting efficacy with good safety.
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 |
|---|---|---|---|
| Nasal Type Extranodal NK/T-Cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MESA
- description
- stage I/II: methotrexate 1000mg/m2,d1 dexamethasone 40mg,d2-d4 etoposide 100mg,d2-d4 pegaspargase 2500U/m2,d5 a cycle of every 21 days with totally 4 cycles Radiotherapy at least 50Gy in dose for the involved local focus is sandwiched after 2 cycles.
- interventionNames
- Drug: Pegaspargase
- Drug: Methotrexate
- Drug: Dexamethasone
- Drug: Etoposide
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 21 days after 4 cycles of chemotherapy
Secondary outcomes (3)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of extranodal NK/T cell lymphoma, nasal type, previously untreated * Age 14 \~ 70 years old * ECOG(Eastern Cooperative Oncology Group）performance status 0\~2 * Stage I to II * Life expectancy\>6 months * Informed consented Exclusion Criteria: * Chemotherapy before * Bone marrow transplantation before * History of malignancy * Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease * LVEF≤50% * Other uncontrollable medical condition that may that may interfere the participation of the study * Lab at enrollment ALT or AST \>3\*ULN, AKP or bilirubin \>2.5\*ULN Creatinine\>1.5\*ULN * Not able to comply to the protocol for mental or other unknown reasons * Pregnant or lactation * HIV infection
References
Publications (0)
Data not yet available
No reference posted for this study.