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

NCT01991158 | Unknown Phase 2 DMC

• 1 other identifier: B2013-030-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Keywords

GAD-M regimen; first line chemotherapy; NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles

  every 6 weeks, up to completion of treatment (approximately 6 months)

Secondary Outcomes (2)

• Progress Free Survival (PFS)

  up to end of follow-up-phase (approximately 5 years)

• Overall Survival (OS)

  up to the date of death (approximately 5 years)

Other Outcomes (7)

• The number of participants with adverse events of grade 3-4

  every 3 weeks, up to completion of treatment (approximately 6 months)

• Epstein-Barr virus(EBV) DNA copies and antibodies

  every 3 weeks,up to completion of treatment(approximately 6 months)

• Plasma β2-microglobulin

  every 3 weeks,up to completion of treatment(approximately 6 months)

Study Arms (1)

GAD-M regimen

EXPERIMENTAL

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

Drug: High dose of methotrexate; Drug: Gemcitabine; Drug: Pegaspargase; Drug: Dexamethasone

Interventions

High dose of methotrexate DRUG

Methotrexate 3.0g/Kg, intravenous drip D1

GAD-M regimen

Gemcitabine DRUG

Gemcitabine 1g/m2 intravenous drip D1,D8

GAD-M regimen

Pegaspargase DRUG

Pegaspargase 2500U/m2 intramuscular injection (IM) D1

GAD-M regimen

Dexamethasone DRUG

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

GAD-M regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 35141162 DERIVED

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Methotrexate; Gemcitabine; pegaspargase; Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Wenqi Jiang, MD

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: November 1, 2020
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

CN (1)