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Brief Title: Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma
Official Title: 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
Study ID: NCT00884286
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Hospitalier Lyon Sud, Lyon, , France
Hôpital Saint- Louis, Paris, , France
Institut Gustave Roussy, Villejuif, , France
Istituto di ematologia e oncologia medica "L. e. A. Seragnoli", Bologna, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Ospedaliero Universitaria de Modena, Modena, , Italy
Instituto Nacional de Enfermedades Neoplásicas (INEN), Surquillo, Lima, Peru
Hospital Español Auxilio Mutuo de Puerto Rico Inc., San Juan, , Puerto Rico
Hospital Clinico de Barcelona, Barcelona, , Spain
Hospital Morales Meseguer, Murcia, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni, Bellinzona, , Switzerland
Name: Vincent Ribrag, MD
Affiliation: Institut Gustave Roussy, France
Role: PRINCIPAL_INVESTIGATOR