A Phase II Multicenter, Open-Label, Clinical And Pharmacokinetic Study of Aplidin® As A 1-Hour Weekly IV Infusion, in Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 12
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a multicenter study to assess the anti-tumour activity,to investigate the safety profile and to obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.
详细描述
A Phase II Multicenter,Open-Label, Clinical And Pharmacokinetic Study Of Aplidin® As A 1-Hour Weekly IV Infusion, In Patients With Relapsed Or Refractory aggressive non-Hodgkin's Lymphoma.
Primary
• To assess the anti-tumour activity of Aplidin® given as a 1-hour weekly IV infusion, in patients with aggressive non-Hodgkin's Lymphoma, relapsing or refractory to a prior therapy.
Secondary
- To further investigate the safety profile of Aplidin® given as 1-hour weekly IV infusion in this patient population.
- To obtain additional pharmacokinetic information for Aplidin® given as 1-hour weekly IV infusion in patients with aggressive non-Hodgkin's Lymphoma.
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
- •Written informed consent
- •Histologically confirmed aggressive lymphomas,
- •Patient requires treatment because NHL relapses
- •Measurable disease
- •Recovery from any non-hematological toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade < 2 symptomatic peripheral neuropathy is allowed.
- •Age > 18 years.
- •Performance status (ECOG) < 2
- •Adequate renal, hepatic, and bone marrow function (assessed < 14 days before inclusion in the study)
- •Left ventricular ejection fraction within normal limits.
排除标准
- •Prior therapy with Aplidin®.
- •Concomitant therapy with any anti-lymphoproliferative agent
- •Acute lymphoblastic leukemia.
- •CNS lymphoma.
- •HIV-associated lymphoma.
- •Prior gene therapy with viral vectors.
- •More than three previous lines of systemic biological agents or chemotherapies. Wash-out periods since the end of the precedent therapy less than:
- •6 weeks for nitroso-urea or high dose chemotherapy
- •3 weeks for other chemotherapies or biological agents
- •4 weeks for radiation or radionuclide therapy (6 weeks in case of prior extensive external beam radiation (more than 25% of bone marrow distribution).
- •4 weeks for major prior surgery
- •30 days for any investigational product
- •4 weeks for immunosuppressive therapy after allogeneic hematopoietic stem cell transplantation.
- •Pregnant or lactating women.
- •Men and women of reproductive potential who are not using effective contraceptive methods
- •History of another neoplastic disease. Exceptions: Non-melanoma skin cancer,cCarcinoma in situ of any site,any other cancer curatively treated and no evidence of disease for at least 10 years.
- •Known cerebral or leptomeningeal involvement.
- •Other relevant diseases or adverse clinical conditions
- •Treatment with any investigational product in the 30 days period before inclusion in the study.
- •Known hypersensitivity to Aplidin®, mannitol, cremophor EL, or ethanol
- •Limitation of the patient's ability to comply with the treatment or follow-up protocol.
研究组 & 干预措施
Arm One
Aplidin® given as a 1-hour weekly IV infusion
干预措施: Aplidin® (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first
The primary objective of the study was the exploration of the efficacy of plitidepsin when given as a weekly 1-hour infusion on Days 1, 8 and 15 in 4-week cycles to patients with relapsed or refractory aggressive non-Hodgkin's Lymphoma. The primary efficacy endpoint was the Objective Response Rate, defined as the combined rate of Complete Response (CR), Unconfirmed Complete Response (CRu) and Partial Response (PR) following the definition of response according to the International Working Group (IWG) criteria for Non-Hodgkin's Lymphoma (NHL).
次要结局
- Time to Subsequent Chemotherapy(All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first)
- Progression-free Survival(All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first)
- Overall Survival(All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first)
- Time to Response Onset(All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first)
- Duration of Response(All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first)
- Time to Progression(All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first)