Clinical trial · Interventional
Treatment of Natural Killer/T Cell Lymphoma-I/II
A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage I/II NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone)
NCT01501136CI-TRIAL-00018575CTTNKTL-I/IIunknownPhase 4ClinicalTrials.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 DDGP regiment (gemcitabine,pegaspargase,cisplatin,dexamethasone) for patients with newly diagnosed stage I/II Natural Killer (NK)/T Cell Lymphoma.
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 and Nasal-type NK/T-cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna | Other | — | UNRESOLVED |
| DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase) | Other | — | UNRESOLVED |
| gemcitabine,pegaspargase,cisplatin,dexamethasone | Other | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| VIPD(cisplatin,Etoposide,Ifosfamide, dexamethasone,Mesna) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- sequential trial,DDGP, radiotherapy
- description
- sequential DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment followed by radiotherapy
- interventionNames
- Other: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)
- type
- EXPERIMENTAL
- label
- sequential trial,VIPD, radiotherapy
- description
- sequential VIPD(cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna) regiment followed by radiotherapy
- interventionNames
- Other: VIPD(cisplatin,Etoposide,Ifosfamide, dexamethasone,Mesna)
- type
- EXPERIMENTAL
- label
- sequential trial, radiotherapy,DDGP
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \> 3 months * Histological confirmed NK/T cell lymphoma * None of chemotherapy or radiotherapy has been previously used * None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) * At least one measurable lesion * None of other serious diseases, cardiopulmonary function is normal * Pregnancy test of women at reproductive age must be negative * Patients could be followed up * None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments. * volunteers who signed informed consent. Exclusion Criteria: * Disagreement on blood sample collection * Patients allergic of any of drug in this regimen or with metabolic disorder * Pregnant or lactating women * Serious medical illness likely to interfere with participation * Serious infection * Primitive or secondary tumors of central nervous system * Chemotherapy or radiotherapy contraindication * The evidence of CNS metastasis * History of peripheral nervous disorder or dysphrenia * patients participating in other clinical trials * patients taking other antitumor drugs * patients estimated to be unsuitable by investigator
References
Publications (1)
- DERIVEDZhang L, Wang Y, Li X, Li L, Wang X, Sun Z, Wu J, Fu X, Zhang X, Yu H, Wang G, Chang Y, Yan J, Zhou Z, Wu X, Nan F, Li W, Zhang M. Radiotherapy vs sequential pegaspargase, gemcitabine, cisplatin and dexamethasone and radiotherapy in newly diagnosed early natural killer/T-cell lymphoma: A randomized, controlled, open-label, multicenter study. Int J Cancer. 2021 Mar 15;148(6):1470-1477. doi: 10.1002/ijc.33329. Epub 2020 Oct 19. PMID 33034052