The trial examines the safety and potential efficacy for pixantrone when substituted for mitoxantrone in the established FND-R chemotherapy regimen for non-Hodgkin's lymphoma (NHL) patients who had failed prior treatment.
77% of patients treated with the drug combination experienced complete disappearance of their tumors. At two years, overall survival is 85%, with a median failure-free survival of 25 months (range, three to 29 months).
Side effects were primarily hematological including neutropenia, febrile neutropenia, lymphopenia, thrombocytopenia and anemia.
“Although many regimens induce responses in patients with relapsed indolent NHL, many of the remissions are of relatively short duration,” noted Dr Jack Singer, chief medical officer at Cell Therepeutics. “These data suggest that use of pixantrone with fludarabine, dexamethasone and rituximab not only offers a very high response rate, but impressive durability.”
The company is also studying pixantrone in an ongoing phase III study in aggressive NHL.