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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
MD Anderson Cancer Center
Houston, Texas, United States
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.