Avastin+ GemAOD As First-Line Treatment in NK/T Cell Lymphoma

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01921790
• Other study ID #: B2013-017-01
• Status: Recruiting
• Phase: Phase 2
• First received: August 3, 2013
• Last updated: August 20, 2013
• Start date: August 2013
• Est. completion date: August 2020

Study information

• Verified date: August 2013
• Source: Sun Yat-sen University
• Contact: Zhiming Li, MD
• Phone: 86-20-87343765
• Email: lizhm[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2020
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Biological:
• Avastin
Avastin 7.5mg/Kg, intravenous drip D1

Drug:
• 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

Locations

Country	Name	City	State
China	Department of Medical Oncology, Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Eli Lilly and Company, Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Epstein-Barr virus(EBV) DNA copies	21 days(3 weeks) for one cycle	every 3 weeks,up to completion of treatment(approximately 6 months)	No
Other	lymphocyte count	21 days(3 weeks) for one cycle	every 3 weeks,up to completion of treatment(approximately 6 months)	No
Other	Monocyte Count	21 days(3 weeks) for one cycle	every 3 weeks,up to completion of treatment(approximately 6 months)	No
Other	C reactive protein	21 days(3 weeks) for one cycle	every 3 weeks,up to completion of treatment(approximately 6 months)	No
Other	Plasma ß2-microglobulin	21 days(3 weeks) for one cycle	every 3 weeks,up to completion of treatment(approximately 6 months)	No
Other	Urinary microglobulin ß2	21 days(3 weeks) for one cycle	every 3 weeks,up to completion of treatment(approximately 6 months)	No
Primary	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)	No
Secondary	Progress Free Survival(PFS)		up to end of follow-up-phase (approximately 5 years)	No
Secondary	Overall Survival(OS)		up to the date of death (approximately 5 years)	No
Secondary	The tolerance and the side effects of the treatment	21 days(3 weeks) for one cycle,Toxicity was evaluated every cycle	every 3 weeks,up to completion of treatment(approximately 6 months)	Yes