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
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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
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Assess and define the tolerability and the side effects of Marqibo in ALL.
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Age >= 18 years.
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Patients with Philadelphia chromosome-negative ALL in second relapse, or patients
with Philadelphia-chromosome-negative ALL who failed two treatment lines of antileukemia chemotherapy.
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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.
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Responsive to a prior anti-leukemia therapy as defined by a leukemia-free interval of
3 months.
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ECOG performance status 0?NC3.
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Burkitt's lymphoma.
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Active CNS disease. History of treated CNS disease is allowable.
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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.
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