KURZPROTOKOLL Marqibo - Universitäres Centrum für
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KURZPROTOKOLL Marqibo - Universitäres Centrum für
KURZPROTOKOLL Marqibo Öffentlicher Titel Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia Wissenschaftl. Titel A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo; (vincristine sulfate liposomes injection) in Adult Patients with Philadelphia Chromosomenegative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients with Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Antileukemia Chemotherapy Kurztitel Marqibo Studienphase Phase II Erkrankung HAEMA: ALL: Rezidiviert/refraktär Ziele - Show if Marqibo is effective in reducing the growth of ALL in second relapse or in ALL that has returned after two different chemotherapy treatments - Assess and define the tolerability and the side effects of Marqibo in ALL. - Age >= 18 years. - Patients with Philadelphia chromosome-negative ALL in second relapse, or patients with Philadelphia-chromosome-negative ALL who failed two treatment lines of antileukemia chemotherapy. - Histologically proven ALL and 10% bone marrow blasts. Diagnostic material of the screening bone marrow aspirate and biopsy must be submitted to the central hematopathologist. - Responsive to a prior anti-leukemia therapy as defined by a leukemia-free interval of 3 months. - ECOG performance status 0?NC3. - Burkitt's lymphoma. - Active CNS disease. History of treated CNS disease is allowable. - Systemic corticosteroids must have been tapered off, preferably before the start of study treatment, but no later than by Day 5 of Course 1. From Day 6 of Course 1 on through the end of study participation, systemic corticosteroids are not allowed, unless the patient shows disease progression or disease relapse, is discontinued from the study treatment, and requires subsequent anti-leukemia therapy. Einschlusskriterien Ausschlusskriterien Alter 18 Jahre und älter Status Geschlossen Beginn der Rekrutierung 01.08.2007 Fallzahl 56 Sponsoren Hana Biosciences, Inc. (Hauptsponsor) l3 Research Registrierung in anderen Studienregistern ClinicalTrials NCT00495079 (primäres Register) Therapie Marqibo; (vincristine sulfate liposomes injection). Patients enrolled will receive Marqibo dose intravenously every 7 days. © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 13.01.2017; Seite 1 von 1