Clinical trial NCT01921790: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Keywords: Avastin+ GemAOD
first line chemotherapy
NK/T-cell Lymphoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: Eli Lilly and Company
First posted: 2013-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Overall Response Rate(ORR)
timeFrame: every 6 weeks,up to completion of treatment(approximately 6 months)
Secondary outcomes:
measure: Progress Free Survival(PFS)
timeFrame: up to end of follow-up-phase (approximately 5 years)
measure: Overall Survival(OS)
timeFrame: up to the date of death (approximately 5 years)
measure: The tolerance and the side effects of the treatment
timeFrame: every 3 weeks,up to completion of treatment(approximately 6 months)
Other outcomes:
measure: Epstein-Barr virus(EBV) DNA copies
timeFrame: every 3 weeks,up to completion of treatment(approximately 6 months)
measure: lymphocyte count
timeFrame: every 3 weeks,up to completion of treatment(approximately 6 months)
measure: Monocyte Count
timeFrame: every 3 weeks,up to completion of treatment(approximately 6 months)
measure: C reactive protein
timeFrame: every 3 weeks,up to completion of treatment(approximately 6 months)
measure: Plasma β2-microglobulin
timeFrame: every 3 weeks,up to completion of treatment(approximately 6 months)
measure: Urinary microglobulin β2
timeFrame: every 3 weeks,up to completion of treatment(approximately 6 months)
Locations:
city: Guangzhou
country: China
facility: Department of Medical Oncology, Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
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
name: Wenqi Jiang, MD
role: PRINCIPAL_INVESTIGATOR
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
name: Zhiming Li, MD
role: PRINCIPAL_INVESTIGATOR
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