Phase II Study of Treatment of Relapsed Agressive Lymphomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Complete remission rate
研究概览
简要总结
The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma
详细描述
Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma.
The study intervention is an administration of 3 courses of the abovementioned drugs, witch doses are detailed below. Remission is assessed and the investigator is free to proceed with any kind of consolidation , he decides best for the patient( high dose or standard chemotherapy).
The addition of Rituximab the the NIMP protocol is warranted on the basis of previous publications wtich have shown a significant advantage in addition to chemotherapy in complete remission rate and in overall survival.
Navelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good toxicity profile for patients who have prevously received anthracyclines, and there is not so much cross resistance between the two drugs.
Ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of its low hematologic toxicity profile and good antitumor activity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders, between 18 and 75 years old
- •CD 20+ large cell lymphoma
- •In first relapse
- •No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation
- •Ann Arbor stage I, II, III ou IV
- •ECOG 0,1 or 2
- •Signed informed consent
排除标准
- •age: before 18 and more than 75 years old
- •other type of lymphoma
- •Informed consent not signed
研究组 & 干预措施
R NIMP
(Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5
干预措施: rituximab (Drug)
R NIMP
(Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5
干预措施: vinorelbine (Drug)
R NIMP
(Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5
干预措施: ifosfamide (Drug)
R NIMP
(Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5
干预措施: Mitoxantrone (Drug)
R NIMP
(Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5
干预措施: Prednisone (Drug)
结局指标
主要结局
Complete remission rate
时间窗: CR AFTER 3 R NIMP COURSES
次要结局
- overall remission rate(OS after 3 R NIMP COURSES)
- Toxicity(R NIMP TOLERANCE)
- Pharmacoeconomy(treatment phramacoeconomy)