NCT01054781已完成2 期
Open-labelled, Multicenter Phase II Study of Intensified 1st Cycle Rituximab Plus 8th Cycles of R-CHOP Chemotherapy in Patients With Advanced or Bulky CD20+ Diffuse Large B-cell Lymphoma (DLBCL)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- To evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL and
研究概览
简要总结
The purpose of this study is to evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed CD20 positive Diffuse Large B-cell Lymphoma (DLBCL)
- •Advanced stage: stage III, IV and/or bulky disease (largest diameter ≥ 10.0 cm) regardless of stage
- •Previously untreated.
- •Performance status: ECOG 0-
- •At least one or more bidimensionally measurable lesion(s)
- •≥ 2 cm by conventional CT
- •≥ 1 cm by spiral CT
- •skin lesion (photographs should be taken) ≥ 2 cm
- •measurable lesion by physical examination ≥ 2 cm
- •Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormalities
- •Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L)
- •Adequate liver functions:
- •Transaminase (AST/ALT) < 3 X upper normal value (or < 5 x ULN in the presence of DLBCL involvement of the liver)
- •Bilirubin < 2 X upper normal value (or < 5 x ULN in the presence of DLBCL involvement of the liver)
- •Adequate hematological function: 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
- •Life expectancy ≥ 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 < 1 years after the onset of menopause.
- •Informed consent
排除标准
- •Other subtypes NHL than DLBCL
- •Patients who transformed follicular lymphoma or other indolent lymphoma
- •Primary Central Nervous System (CNS) DLBCL;
- •CNS involvement by lymphoma or any evidence of spinal cord compression. Brain CT/MRI is only mandatory (within 4 weeks) in case of clinical suspicion of CNS involvement by lymphoma. Patients who have only had prophylactic intrathecal chemotherapy against CNS disease are eligible.
- •Patients with a known history of HIV seropositivity or HCV (+). Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) 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
- •Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- •History of significant neurological or psychiatric disorders including dementia or seizures
- •Active uncontrolled infection (viral, bacterial or fungal infection)
- •Other serious medical illnesses
- •Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
- •Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
结局指标
主要结局
To evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL and
时间窗: 12 months
次要结局
- To evaluate the overall response rate of R+R-CHOP(12 months)
- To evaluate the duration of overall response(12 months)
- To evaluate the safety and tolerability of the R+R-CHOP combination treatment.(12 months)
- To evaluate the progression free survival.(12 months)
- To estimate the overall survival.(12 months)
- To explore prognostic or predictive biomarkers(12 months)
研究者
研究点 (2)
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