Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma
NCT ID: NCT01921790
Last Updated: 2013-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2013-08-31
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Avastin+ GemAOD
Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone
Avastin
Avastin 7.5mg/Kg, intravenous drip D1
Gemcitabine
Gemcitabine 1g/m2 intravenous drip D1,D8
Oxaliplatin
Oxaliplatin 130mg/m2 intravenous drip D1
Pegaspargase
Pegaspargase 2500U/m2 intramuscular injection (IM) D1
Dexamethasone
Dexamethasone 20mg/d intravenous drip D1, po D2-3
Interventions
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Avastin
Avastin 7.5mg/Kg, intravenous drip D1
Gemcitabine
Gemcitabine 1g/m2 intravenous drip D1,D8
Oxaliplatin
Oxaliplatin 130mg/m2 intravenous drip D1
Pegaspargase
Pegaspargase 2500U/m2 intramuscular injection (IM) D1
Dexamethasone
Dexamethasone 20mg/d intravenous drip D1, po D2-3
Eligibility Criteria
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Inclusion Criteria
* Age:18-80 years;
* Eastern Cooperative Oncology Group (ECOG) status 0-3, Estimated survival time \> 3 months;
* Normal haematological, liver and renal function (WBC count≥4×109/L, Hemoglobin≥100g/L, platelet count≥100×109/L, bilirubin\<1.5×ULN, Alanine transaminase (ALT) or Aspartate Aminotransferase (AST)\<2.5×ULN, serum creatinine\<1.5×ULN), normal coagulation function and cardiac function;
* Appreciable and measurable lesions ;
* No history of other malignancies;
* No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation;
* 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 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;
* The patients suffered before surgery less than four weeks, or after less than six weeks;
* The patients with major vascular invasion;
* 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 moderate to severe proteinuria;
* Severe hypertension,BP≥160/100mmHg;
* 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 to test drug;
* The patients not suitable to participate in the investigator judged by researchers.
18 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Eli Lilly and Company
INDUSTRY
Sun Yat-sen University
OTHER
Responsible Party
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Li Zhiming
Clinical Professor
Principal Investigators
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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
Zhiming Li, 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
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Department of Medical Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Zhiming Li, MD
Role: primary
Yu Wang, MD
Role: backup
Other Identifiers
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B2013-017-01
Identifier Type: -
Identifier Source: org_study_id