NCT00244127Unknown2 期
Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- Response rate
研究概览
简要总结
To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the R-CHOP regimen.
详细描述
To evaluate the duration of remission, disease free survival and 2-year survival of R-COMP in first line therapy of elderly patients with advanced aggressive NHL.
To evaluate the tolerability of R-COMP in first line therapy of elderly patients with advanced aggressive NHL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diffuse Large B-Cell Lymphoma (DLBCL), and their morphologic variants and subtypes, i.e. Centroblastic lymphoma, Immunoblastic lymphoma, T-cell rich/B-cell lymphoma, anaplastic large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma;
- •Primary diffuse large B-cell lymphoma of MALT (incorrectly defined as high-grade MALT lymphoma);
- •Marginal zone B-cell lymphoma with coexisting areas of DLBCL;
- •Age of ≥60 years;
- •Clinical stage at diagnosis: I A bulky - IV B;
- •CD20 positivity;
- •Serum negativity for HbsAg and HCV except for those with no sign of active viral replication, assessed by HCV-RNA copies;
- •Absolute neutrophil count (ANC) ≥1.5x109/L, and platelet count ≥100x109/L (unless both are attributed directly to bone marrow involvement by lymphoma or auto-immune disease secondary to lymphoma);
- •Serum creatinine ≤130μM/L, serum bilirubin ≤2.5xULN aspartate amino-transferase (AST/GOT), ≤2.5xULN alanine amino-transferase (ALT/GPT) ≤2.5xULN, and alkaline phosphatase ≤4 times the upper limit of normal (unless the increase is attributed directly to the presence of tumour by the Investigator)
- •Left ventricular ejection fraction (LVEF) ≥50%;
- •ECOG performance status 0-2;
- •At least one measurable lesion is mandatory;
- •Written informed consent given at time of registration;
- •Males and females (both males and females of childbearing potential must agree to use adequate contraception for the duration, and for 3 months after the completion, of the treatment).
排除标准
- •Clinical stage I non-bulky, or CS IIA with less than three sites of disease involved (patients with stage IIB are eligible, regardless of the number of sites involved);
- •Tumour involvement of CNS;
- •Indolent lymphoma transformed in more aggressive histological type, even if never previously treated;
- •Mantle Cell Lymphoma, Peripheral T cell Lymphoma and their variants;
- •Aggressive non-Hodgkin's lymphoma in transplanted patient;
- •Clinically significant secondary cardiovascular disease, e.g. uncontrolled hypertension, (resting diastolic blood pressure >115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV;
- •Evidence of any severe active acute or chronic infection;
- •Concurrent malignancy or history of other malignancy, except basal cell carcinoma of the skin (BCC) and in-situ cervical carcinoma (CIN) / Myelodysplastic syndrome;
- •HbsAg, HIV-positive, or HCV-RNA-positive patients;
- •Inability to comply with study procedures;
- •Prior CNS lymphoma;
- •Prior radiation to non-CNS lymphoma mass(es) as a treatment for lymphomas;
- •History of allergic reaction to anthracyclines, eggs, and egg products or known sensitivities, or history of unusual reaction, to other components of, or treatments similar to, the investigational treatment regimen;
- •Presence of other medication that may interfere with study treatment or the action of the investigational product or confuse the assessment of study results
- •Pregnant women or nursing mothers;
- •Participation in an investigational drug study within 4 weeks prior to study entry.
结局指标
主要结局
Response rate
次要结局
未报告次要终点
研究者
研究点 (6)
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