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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
PharmaMar,0 个研究点目标入组 0 人开始时间: 2009年2月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •Obtain written informed consent before the start of any specific study procedure.
- •Histologically confirmed aggressive lymphomas
- •The patient requires treatment because NHL has recurred after the response to chemotherapy at standard or high doses + germ cell transplantation, or NHL is refractory (that is, it has not been possible to achieve at least RC, RP or EE) at most recent chemotherapy.
- •Autotransplantation and / or germ cell allotransplantation is allowed. In case of hematopoietic germ cell allogeneic transplantation (HSCT), the patient must be without immunosuppressive medication before being able to be included.
- •The disease is measurable: existence of a two-dimensional lesion larger than 2 cm in its largest diameter or malignant lymphocytosis greater than 5 x 10 ^ / L. Another procedure for the formulation of measurable disease could be allowed in a given case if approved by PharmaMar.
- •Resolution of all non-hematological toxicity resulting from previous treatments. The presence of alopecia and symptomatic peripheral neuropathy of grade <2 of NCI CTCs is allowed.
- •Age> 18 years.
- •Functional status (ECOG) <2
- •Appropriate renal, hepatic and bone marrow functions (evaluated <14 days before inclusion in the study)
排除标准
- •Pretreatment with Aplidin®
- •Concomitant treatment with any antilinfoproliferative agent, including glucocorticoids at a daily dose greater than 10 mg of prednisone or equivalent, unless they were indicated for symptom control and disease progression had been documented while the patient was on steroids.
- •Acute lymphoblastic leukemia.
- •Lymphoma in CNS.
- •Lymphoma associated with HIV.
- •Previous gene therapy with viral vectors.
- •More than three previous lines of systemic biological agents or systemic chemotherapies. (Bone marrow transplantation and germ cell transplantation as consolidation therapy of a previous response are considered as a chemotherapy line).
- •Washing periods from the end of the previous treatment under: 6 weeks for chemotherapy with nitrosoureas or high-dose chemotherapy, 3 weeks for other chemotherapies or biological agents, 4 weeks for radiotherapy or radionuclide treatment (6 weeks in the case of previous extensive external radiotherapy (distribution over more than 25% of bone marrow)), 4 weeks for previous major surgery, 30 days for any product under investigation, 4 weeks for immunosuppressive treatment after germ cell allogeneic transplantation hematopoietic
- •Pregnant or breastfeeding women.
- •Men and women of childbearing age who do not use effective contraceptive methods
- •History of another neoplastic disease, except: Nonmelanoma skin cancer, Carcinoma in situ of any area, Any other neoplasm treated curatively and without evidence of disease for at least 10 years.
- •Known cerebral or leptomeningeal involvement.
- •Other relevant adverse clinical conditions or situations
- •Treatment with any product under investigation within the period of 30 days prior to 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 indicated in the protocol.
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