NCT02544425Unknown2 期
Phase II Study of VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) Chemotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Stage III/IV Extranodal NK-T-Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
Open-labeled, multicenter phase II study of VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) chemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation in patients with stage III/IV extranodal NK/T-cell Lymphoma.
详细描述
Extranodal NK/T cell lymphoma (ENKTL) is a rare and aggressive lymphoma subtype, but standard front-line therapy has not been established. The clinical outcome of patients (pts) with ENKTL after the treatment of conventional chemotherapy, especially pts with advanced stage, was generally poor. Therefore, high-dose chemotherapy followed by autologous stem cell transplantation (ASCT) as a consolidation could be one of promising strategies to improve the outcome of ENKTL. However, there have been few studies reporting the survival outcome or prognostic significances of front-line ASCT in pts with ENKTL. Thus, the aim of this study was to investigate the outcome of patients with advanced-stage ENKTL who had undergone front-line ASCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed extranodal NK/T cell lymphoma
- •Aged between 19 and 65 years
- •Previously untreated history
- •Performance status: Eastern Cooperative Oncology Group 0-2
- •Ann Arbor stage III and IV
- •At least one in positron emission tomograph(PET)/CT positive lesion or in 2-dimensional computerized tomography
- •mass lesions more than 2 cm by conventional CT or more than 1 cm by spiral CT
- •Skin lesions or physically detected mass more than 2 cm
- •Cardiac ejection fraction ≥ 45 % as measured by multiple gated acquisition scan(MUGA) or 2D echogram(ECHO) without clinically significant abnormalities
- •Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value(or < 5 x upper limit of normal in the presence of NK/T lymphoma involvement of the liver)
- •Bilirubin < 2 X upper normal value(or < 5 x upper limit of normal in the presence of DLBCL involvement of the liver)
- •Serum Creatinine < 2.0 mg/dL
- •Adequate bone marrow functions: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma
- •Expected life is more than 180 days (more than 6 months)
- •A negative serum or urine pregnancy test prior to treatment must be available both for pre-menopausal women and for women who are < 1years after the onset of menopause. Premenopausal women should be treated with appropriate contraception such as hormone contraception, intra-uterine device, spermicidal condom and etc. during and one month after the treatment.
- •Voluntarily signed the informed consent including fully understand of clinical procedures and processing steps for the clinical trial
排除标准
- •Patients who have serious medical condition, abnormal laboratory results or psychiatric problems
- •Other subtypes non-Hodgkin's lymphoma than NK/T cell lymphoma
- •Patients who have aggressive NK/T cell leukemia
- •NK/T cell lymphoma with Primary Central Nervous System (CNS) involvement. However, patients who have only had prophylactic intrathecal chemotherapy against CNS disease are eligible.
- •Patients with a known history of HIV seropositivity or hepatitis C virus (HCV) (+). Patients who have carrier hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
- •Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •Other serious illness or medical conditions i. Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry ii. History of significant neurologic or psychiatric disorders including dementia or seizures iii. Active uncontrolled infection (viral, bacterial or fungal infection) iv. Other serious medical illnesses
- •Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
- •Serious allergy history for experimental drugs
- •Patients who contraindication to the study drug use
研究组 & 干预措施
VIDL+ASCT
Experimental
- VIDL Induction (repeated 28 days) : VP-16, Ifosfamide, Dexamethasone, L-asparaginase
- Peripheral blood stem cell mobilization:Etoposide
- Conditioning regimen for autologous stem cell transplantation:Busulfan,Melphalan,Etoposide
干预措施: Etoposide (Drug)
VIDL+ASCT
Experimental
- VIDL Induction (repeated 28 days) : VP-16, Ifosfamide, Dexamethasone, L-asparaginase
- Peripheral blood stem cell mobilization:Etoposide
- Conditioning regimen for autologous stem cell transplantation:Busulfan,Melphalan,Etoposide
干预措施: Ifosfamide (Drug)
VIDL+ASCT
Experimental
- VIDL Induction (repeated 28 days) : VP-16, Ifosfamide, Dexamethasone, L-asparaginase
- Peripheral blood stem cell mobilization:Etoposide
- Conditioning regimen for autologous stem cell transplantation:Busulfan,Melphalan,Etoposide
干预措施: Dexamethasone (Drug)
VIDL+ASCT
Experimental
- VIDL Induction (repeated 28 days) : VP-16, Ifosfamide, Dexamethasone, L-asparaginase
- Peripheral blood stem cell mobilization:Etoposide
- Conditioning regimen for autologous stem cell transplantation:Busulfan,Melphalan,Etoposide
干预措施: L-asparaginase (Drug)
VIDL+ASCT
Experimental
- VIDL Induction (repeated 28 days) : VP-16, Ifosfamide, Dexamethasone, L-asparaginase
- Peripheral blood stem cell mobilization:Etoposide
- Conditioning regimen for autologous stem cell transplantation:Busulfan,Melphalan,Etoposide
干预措施: Busulfan (Drug)
VIDL+ASCT
Experimental
- VIDL Induction (repeated 28 days) : VP-16, Ifosfamide, Dexamethasone, L-asparaginase
- Peripheral blood stem cell mobilization:Etoposide
- Conditioning regimen for autologous stem cell transplantation:Busulfan,Melphalan,Etoposide
干预措施: Melphalan (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: 2 years
次要结局
- objective overall response rate(2 years)
- Number of subjects with Adverse Events as a Measure of safety and tolerability(2 years)
- overall survival(4 years)
研究者
Won Seog Kim
Professor
Samsung Medical Center
研究点 (1)
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