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news.An independent data monitoring committee has recommended that Cell Therapeutics' phase III trial investigating pixantrone in aggressive non-Hodgkin's lymphoma continue based on encouraging preliminary findings.
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The recommendation is based on preliminary encouraging confirmed and unconfirmed complete response (CR/uCR) rates observed among the first 40 patients with aggressive non-Hodgkin’s lymphoma (NHL) treated in the randomized phase III trial, which is named EXTEND.
The EXTEND clinical trial is a phase III study in patients with relapsed, aggressive non-Hodgkin’s lymphoma who have received two or more prior therapies. It is being conducted in 130 sites across 17 countries.
In the trial, patients are randomized to receive either pixantrone or another single-agent drug of physician’s choice currently used for the treatment of this patient population. The trial is designed to examine the complete response or unconfirmed complete response rate, time to tumor progression, and overall survival.
Pixantrone was developed to improve the activity and safety of the anthracycline family of anticancer agents. Anthracyclines have been shown to be very active clinically in a number of tumor types but they are usually associated with cumulative heart damage, preventing them from being used in a large proportion of patients. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities, as well as to potentially increase activity and simplified administration compared to currently marketed anthracyclines.