Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma
Primary Purpose
Extranodal NK/T-cell Lymphoma, Nasal Type
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Avastin
Gemcitabine
Oxaliplatin
Pegaspargase
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma, Nasal Type focused on measuring Avastin+ GemAOD, first line chemotherapy, NK/T-cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Histologic diagnosis of NK/T Cell Lymphoma;
- 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 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;
- 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.
Sites / Locations
- Department of Medical Oncology, Sun Yat-Sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Avastin+ GemAOD
Arm Description
Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone
Outcomes
Primary Outcome Measures
Overall Response Rate(ORR)
21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles
Secondary Outcome Measures
Progress Free Survival(PFS)
Overall Survival(OS)
The tolerance and the side effects of the treatment
21 days(3 weeks) for one cycle,Toxicity was evaluated every cycle
Full Information
NCT ID
NCT01921790
First Posted
August 3, 2013
Last Updated
August 20, 2013
Sponsor
Sun Yat-sen University
Collaborators
Hoffmann-La Roche, Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT01921790
Brief Title
Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma
Official Title
An Open-Label, Uncontrolled, Single Centered Phase Ⅱ Study of Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone (Avastin+ GemAOD) As First-Line Treatment in Patients With Untreated NK/T Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Hoffmann-La Roche, Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of avastin combined with gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line treatment in patients with untreated natural killer(NK)/T cell lymphoma
Detailed Description
Recent study showed that vascular endothelial growth factor (VEGF) was associated with a poorer outcome in patients with Non-Hodgkin's Lymphoma,and Avastin impacted on tumor endothelial cells to make standard chemotherapy work better for T cell lymphoma. Many researches on Gemcitabine combined with Oxaliplatin for treatments of recurrent and refractory Non-Hodgkin's lymphoma showed patients could benefit from the combination treatment . Pegaspargase plays an important role for treatment of NK/T cell lymphoma. 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 Avastin combined with gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line treatment in patients with untreated NK/T cell lymphoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK/T-cell Lymphoma, Nasal Type
Keywords
Avastin+ GemAOD, first line chemotherapy, NK/T-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Avastin+ GemAOD
Arm Type
Experimental
Arm Description
Avastin+ GemAOD means Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone
Intervention Type
Biological
Intervention Name(s)
Avastin
Intervention Description
Avastin 7.5mg/Kg, intravenous drip D1
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1g/m2 intravenous drip D1,D8
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin 130mg/m2 intravenous drip D1
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Intervention Description
Pegaspargase 2500U/m2 intramuscular injection (IM) D1
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 20mg/d intravenous drip D1, po D2-3
Primary Outcome Measure Information:
Title
Overall Response Rate(ORR)
Description
21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles
Time Frame
every 6 weeks,up to completion of treatment(approximately 6 months)
Secondary Outcome Measure Information:
Title
Progress Free Survival(PFS)
Time Frame
up to end of follow-up-phase (approximately 5 years)
Title
Overall Survival(OS)
Time Frame
up to the date of death (approximately 5 years)
Title
The tolerance and the side effects of the treatment
Description
21 days(3 weeks) for one cycle,Toxicity was evaluated every cycle
Time Frame
every 3 weeks,up to completion of treatment(approximately 6 months)
Other Pre-specified Outcome Measures:
Title
Epstein-Barr virus(EBV) DNA copies
Description
21 days(3 weeks) for one cycle
Time Frame
every 3 weeks,up to completion of treatment(approximately 6 months)
Title
lymphocyte count
Description
21 days(3 weeks) for one cycle
Time Frame
every 3 weeks,up to completion of treatment(approximately 6 months)
Title
Monocyte Count
Description
21 days(3 weeks) for one cycle
Time Frame
every 3 weeks,up to completion of treatment(approximately 6 months)
Title
C reactive protein
Description
21 days(3 weeks) for one cycle
Time Frame
every 3 weeks,up to completion of treatment(approximately 6 months)
Title
Plasma β2-microglobulin
Description
21 days(3 weeks) for one cycle
Time Frame
every 3 weeks,up to completion of treatment(approximately 6 months)
Title
Urinary microglobulin β2
Description
21 days(3 weeks) for one cycle
Time Frame
every 3 weeks,up to completion of treatment(approximately 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic diagnosis of NK/T Cell Lymphoma;
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 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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiming Li, MD
Phone
86-20-87343765
Email
lizhm@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, MD
Phone
86-20-87343349
Email
wangyu@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenqi Jiang, MD
Organizational Affiliation
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
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhiming Li, MD
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Oncology, Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Li, MD
Phone
+86-13719189172
Email
lizhm@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Yu Wang, MD
Phone
+86-20-87343765
Email
wangyu@sysucc.org.cn
12. IPD Sharing Statement
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Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma
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