Pixantrone (BBR 2778) in Patients With Refractory Acute Myelogenous Leukemia (AML)
The goal of this study is to find the safest dose of Pixantrone (BBR 2778) that can be given to patients with Acute Myelogenous Leukemia (AML). After the safest dose is found, up to an additional 86 patients will be enrolled. During this part of the study, the safety and effectiveness will be evaluated.
Acute Myelogenous Leukemia
Drug: Pixantrone IV infusion
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Pixantrone (BBR 2778) in Patients With Refractory Acute Myelogenous Leukemia (AML)|
- Phase I: To determine the maximum tolerated dose (MTD) of Pixantrone (BBR 2778) in patients with refractory acute myelogenous leukemia (AML)
- Phase II: To evaluate the activity of pixantrone in this patient population in terms of objective responses
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||March 2007|
This is an open label, single center, phase I/II study of pixantrone in patients with refractory AML. Pixantrone will be administered for three consecutive days on days 1, 2 and 3 of each 21-day cycle, for up to two cycles.
The study has 2 parts; phase I and phase II. In the phase I part of the study, the maximum tolerated dose (MTD) for pixantrone as a single agent in patients with refractory AML will be determined. In the phase II part of the study, up to an additional 86 patients will be treated at the MTD to assess disease response.