Clinical trial · Interventional
GAD-M Regimen As First-Line Treatment in Untreated Extranodal NK/T Cell Lymphoma
An Open, Single-center, Phase II Clinical Trial for Treatment of Untreated Extranodal NK/T Cell Lymphoma With High Dose of Methotrexate in Combination With Gemcitabine, Pegaspargase and Dexamethasone (GAD-M Regimen)
NCT01991158CI-TRIAL-00022582unknownPhase 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 High dose of Methotrexate combined with gemcitabine, pegaspargase and dexamethasone (GAD-M regimen) as first-line treatment in patients with de novo extranodal 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 |
|---|---|---|---|
| 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 |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| High dose of methotrexate | Drug | — | UNRESOLVED |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GAD-M regimen
- description
- GAD-M regimen means High dose of methotrexate combined with gemcitabine, pegaspargase and dexamethasone
- interventionNames
- Drug: High dose of methotrexate
- Drug: Gemcitabine
- Drug: Pegaspargase
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- every 6 weeks, up to completion of treatment (approximately 6 months)
- description
- 21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles
Secondary outcomes (2)
- measure
- Progress Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of NK/T Cell Lymphoma; * Age:18-80 years; * Weight:Male:67±20Kg(47-87Kg),Female:55±20Kg(35-75Kg) * Eastern Cooperative Oncology Group (ECOG) status 0-3, Estimated survival time \> 3 months; * No history of other malignancies; No other current tumors; * Normal haematological, liver and renal function (WBC count≥3.5×109/L, Hemoglobin≥100g/L, platelet count≥90×109/L, bilirubin\<1.5×ULN, Alanine transaminase (ALT) and Aspartate Aminotransferase (AST)\<2.5×ULN, serum creatinine\<1.5×ULN), normal coagulation function and cardiac function; * Clinical staging I-IV; * No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation; * Appreciable and measurable lesions, clinical assessment \>2cm,CT or MRI \>1.5cm; * No other serious diseases which conflict with the treatment in the present trial; * No concurrent treatments that conflict with the treatments in the present trial(including steroid drugs); * Voluntary participation and signed the informed consent. Exclusion Criteria: * The patients had the conditions below: clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), symptomatic coronary artery heart disease requiring medication; * The patients suffered from organ transplant * The patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies; * The patients with active bleeding or new thrombotic disease, who are taking anticoagulant drugs or with a history of bleeding tendencies,who with active infection; * The patients suffered before surgery less than four weeks, or after less than six weeks; * The patients with abnormal liver function (total bilirubin\> 1.5 times the normal value, ALT / AST\> 2.5 times normal), abnormal renal function (serum creatinine\> 1.5 times normal), blood abnormalities (absolute neutrophil count \<1.5 × 109 / L, platelets \<80 × 109 / L, hemoglobin \<90g /L) ; * The patients with mentally ill / unable to obtain informed consent; * The patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results; * The patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects; * Clinical and laboratory support brain metastases; * The patients with a history of allergy or adverse reaction(s) to test drug; * The patients not suitable to participate in the investigator judged by researchers.
References
Publications (1)
- DERIVEDWang Y, Wang CQ, Sun P, Liu PP, Yang H, Wang HY, Rao HL, Li S, Jiang WQ, Huang JJ, Li ZM. Phase II Study of Gemcitabine, Peg-Asparaginase, Dexamethasone and Methotrexate Regimen for Newly Diagnosed Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type: Final Analysis With Long-Term Follow-Up and Rational Research for the Combination. Front Oncol. 2022 Jan 24;12:796738. doi: 10.3389/fonc.2022.796738. eCollection 2022. PMID 35141162