NCT00974792Unknown2 期
A Phase II Single Arm Study of the Use of CODOX-M/IVAC With Rituximab (R-CODOX-M/IVAC) in the Treatment of Patients With Diffuse Large B-Cell Lymphoma (International Prognostic Index High or High-Intermediate Risk)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Giving more than one drug (combination chemotherapy) together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with diffuse large B-cell non-Hodgkin lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the complete response rate in patients with high- or high/intermediate-risk diffuse large B-cell lymphoma treated with CODOX-M/IVAC comprising cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, methotrexate, ifosfamide, etoposide phosphate, and cytarabine with rituximab.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the progression-free survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diffuse large B-cell non-Hodgkin lymphoma
- •International Prognostic Index (IPI) score high-intermediate (score = 3) OR high (score = 4 or 5), defined as:
- •Stage III or IV disease
- •Raised lactic dehydrogenase and poor performance status (WHO performance status 2-4)
- •All morphological variants included
- •B-cell nature of the proliferation must be verified by a positive anti-CD20 antibody (i.e., CD20-positive disease)
- •No T-cell lymphoma
- •No history of treated or non-treated indolent lymphoma
- •Patients newly diagnosed who have large B-cell lymphoma with some small cell infiltration in the bone marrow or lymph node may be allowed
- •PATIENT CHARACTERISTICS:
- •See Disease Characteristics
- •Life expectancy > 3 months
- •ANC > 1,500/mm^3*
- •Platelet count > 100,000/mm^3*
- •Serum creatinine < 150 μmol/L*
- •Serum bilirubin < 35 μmol/L*
- •AST and/or ALT < 2.5 times upper limit of normal* NOTE: *Unless attributed to bone marrow infiltration by lymphoma.
- •Fertile patients must use effective contraception
- •Normal MUGA or echocardiogram without areas of abnormal contractility
- •LVEF ≥ 50% and only tested if patient meets 1 of the following criteria:
- •History of diabetes
- •Prior cardiac disease, hypertension, or abnormal resting ECG
- •No history of heart failure or uncontrolled angina pectoris
- •No cardiac contraindication to doxorubicin hydrochloride (e.g., abnormal contractility on echocardiography or MUGA)
- •No neurological contraindication to vincristine sulfate (e.g., pre-existing diabetic neuropathy)
- •No concurrent uncontrolled medical condition
- •No other serious active disease
- •No general status that, according to the investigator, does not allow the administration of 2 courses of CODOX-M/IVAC
- •No active malignant disease within the past 10 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
- •No positive serology for HIV or hepatitis B or C
- •No medical or psychiatric conditions that compromise the patient's ability to give informed consent
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior chemotherapy, radiotherapy, or other investigational drug for diffuse large B-cell non-Hodgkin lymphoma
排除标准
- 未提供
结局指标
主要结局
Complete response rate
次要结局
- Toxicity
- Progression-free survival
研究者
研究点 (1)
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