GAD-M Regimen As First-Line Treatment in Untreated Extranodal NK/T Cell Lymphoma

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: Eli Lilly and Company
• Treatments: Asparaginase; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gemcitabine; Methotrexate; Pegaspargase

Criteria

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.