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UNKNOWNPHASE2

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)

NCT01991158•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

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;
+2 more criteria

Locations (1)

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

Guangzhou, Guangdong, China

Key Dates

Start Date

November 1, 2013

Primary Completion Date

December 1, 2016

Completion Date

November 1, 2020

Last Updated

June 14, 2016

Enrollment

ESTIMATED participants

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Interventions

High dose of methotrexate

DRUG

Gemcitabine

DRUG

Pegaspargase

DRUG

Dexamethasone

DRUG

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

NCT03493451

Peripheral T Cell LymphomaPTCL+17 more

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TERMINATEDPHASE1/PHASE2

Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL

NCT04509466

Extranodal NK/T-cell Lymphoma, Nasal Type

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL

Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL

Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma

Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma