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

NCT ID: NCT01991158

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2020-11-30

Brief 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.

Detailed Description

Studies have shown that effects of P glycoprotein mediated chemotherapy resistance reduce the therapeutic efficacy of anthracycline-based chemotherapy of NK/T cell lymphoma, and agents like pegaspargase and large doses of Methotrexate is not affected by the P glycoprotein. A number of reports suggest that gemcitabine combined with other chemotherapy drugs has good application prospect in the treatment of lymphomas. Dexamethasone is used in combination with other agents for the treatment of lymphomas which may be implicated in the development or growth of some cancers. So we explored 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 untreated extranodal NK/T cell lymphoma.

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GAD-M regimen

GAD-M regimen means High dose of methotrexate combined with gemcitabine, pegaspargase and dexamethasone

Group Type: EXPERIMENTAL

High dose of methotrexate

Intervention Type: DRUG

Methotrexate 3.0g/Kg, intravenous drip D1

Gemcitabine

Intervention Type: DRUG

Gemcitabine 1g/m2 intravenous drip D1,D8

Pegaspargase

Intervention Type: DRUG

Pegaspargase 2500U/m2 intramuscular injection (IM) D1

Dexamethasone

Intervention Type: DRUG

Dexamethasone 20mg/d intravenous drip D1, po D2-3

Interventions

High dose of methotrexate

Methotrexate 3.0g/Kg, intravenous drip D1

Intervention Type: DRUG

Gemcitabine

Gemcitabine 1g/m2 intravenous drip D1,D8

Intervention Type: DRUG

Pegaspargase

Pegaspargase 2500U/m2 intramuscular injection (IM) D1

Intervention Type: DRUG

Dexamethasone

Dexamethasone 20mg/d intravenous drip D1, po D2-3

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhiming

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenqi Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, China

Locations

Department of Medical Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

Wang 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.

Reference Type: DERIVED

PMID: 35141162 (View on PubMed)

Other Identifiers

B2013-030-01

Identifier Type: -

Identifier Source: org_study_id