The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Initial Treatment of Patients With Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
270 untreated patients, age between 18 and 65 years , with diffuse large B-cell lymphoma (B-DLCL) were treated with a pegylated liposomal doxorubicin (PL-doxorubicin) modified CHOP-rituximab regimen. PL-doxorubicin 35-40 mg/m(2)and epirubicin 70mg/m(2) were given in combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab (according to CHOP-R regimen) every 21 days for six courses.
详细描述
PL-doxorubicin 35-40 mg/m(2) and epirubicin 70mg/m(2) were given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21days for six courses. The choice to adopt the dosage of 30 mg/m2(instead of 50 mg/m2 of conventionaldoxorubicin) was based on pharmacokinetic data and on the results of previous studies in lymphoma.Rituximab 375 mg/m2 was given on day 0 in subsequent courses of therapy. Granulocyte colony-stimulating factor was given in the presence of grade 4 neutropenia or febrile neutropenia until hematological recovery. Treatment was stopped if lymphoma progressed, the patient refused further participation,or if there was any other intercurrent clinical condition or adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Diagnosis of previously-untreated DLBCL(patients with a transformed untreated low-grade lymphoproliferative disease were accepted)
- •ECOG performance status < 3 (and higher if due to lym-phoma)
- •No symptomatic cardiac arrythmias or heart failure
- •Acceptable renal, hepatic and pulmonary function
- •Standard laboratory and radiological staging procedures and left ventricular ejection fraction analysis by echocardiography or scintigraphy were required before therapy in all cases
- •The protocol was approved by the ethics review committee of each partici- pating center
- •All patients gave informed written consent.
排除标准
- •Patients with a previous history of cardiac disease;
- •HIV-HBsAg-HCV positivity, central nervous system involvement or any other major clinicalcondition;
- •Other than lymphoma, which might have precluded a regular therapeutic course, were excluded from the study.
研究组 & 干预措施
pegylated liposomal doxorubicin
PL-doxorubicin 35-40 mg/m(2) was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21 days for six courses;Rituximab 375 mg/m(2) was given on day 0.
干预措施: PL-doxorubicin and epirubicin (Drug)
Epirubicin
Epirubicin 70 mg/m(2) was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21 days for six courses;Rituximab 375 mg/m(2) was given on day 0.
干预措施: PL-doxorubicin and epirubicin (Drug)
结局指标
主要结局
overall response rate
时间窗: up to 19 months
次要结局
未报告次要终点