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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991158
First Posted: November 25, 2013
Last Update Posted: June 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Li Zhiming, Sun Yat-sen University
  Purpose
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.

Condition Intervention Phase
Extranodal NK/T-cell Lymphoma, Nasal Type Drug: High dose of methotrexate Drug: Gemcitabine Drug: Pegaspargase Drug: Dexamethasone Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Li Zhiming, Sun Yat-sen University:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: every 6 weeks, up to completion of treatment (approximately 6 months) ]
    21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles


Secondary Outcome Measures:
  • Progress Free Survival (PFS) [ Time Frame: up to end of follow-up-phase (approximately 5 years) ]
  • Overall Survival (OS) [ Time Frame: up to the date of death (approximately 5 years) ]

Other Outcome Measures:
  • The number of participants with adverse events of grade 3-4 [ Time Frame: every 3 weeks, up to completion of treatment (approximately 6 months) ]
    21 days (3 weeks) for one cycle, Toxicity was evaluated every cycle

  • Epstein-Barr virus(EBV) DNA copies and antibodies [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle

  • Plasma β2-microglobulin [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle

  • Urinary microglobulin β2 [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle

  • lymphocyte count [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) 21 ]
    21 days(3 weeks) for one cycle

  • Monocyte Count [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle

  • C reactive protein [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    21 days(3 weeks) for one cycle


Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GAD-M regimen
GAD-M regimen means High dose of methotrexate combined with gemcitabine, pegaspargase and dexamethasone
Drug: High dose of methotrexate
Methotrexate 3.0g/Kg, intravenous drip D1
Drug: Gemcitabine
Gemcitabine 1g/m2 intravenous drip D1,D8
Drug: Pegaspargase
Pegaspargase 2500U/m2 intramuscular injection (IM) D1
Drug: Dexamethasone
Dexamethasone 20mg/d intravenous drip D1, po D2-3

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991158


Locations
China, Guangdong
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Eli Lilly and Company
Investigators
Principal Investigator: 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
  More Information

Responsible Party: Li Zhiming, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01991158     History of Changes
Other Study ID Numbers: B2013-030-01
First Submitted: November 7, 2013
First Posted: November 25, 2013
Last Update Posted: June 14, 2016
Last Verified: June 2016

Keywords provided by Li Zhiming, Sun Yat-sen University:
GAD-M regimen
first line chemotherapy
NK/T-cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
Dexamethasone
Gemcitabine
Pegaspargase
Methotrexate
Asparaginase
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors