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news.Cell Therapeutics has launched its Phase III clinical trial, known as PIX303, of pixantrone for patients with indolent non-Hodgkin's lymphoma who have relapsed following first-line therapy.
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The randomized trial enrolls 300 patients and expects to complete over a 12 to 16-month period. Depending on the rate of progression, an interim analysis is targeted for 2009.
The trial will examine progression-free survival, which is the rate at which a patient’s lymphoma recurs or progresses, following treatment with pixantrone, fludarabine and rituximab (FP-R), compared to treatment with fludarabine and rituximab.
James Bianco, president and CEO, said: “We have previously shown in a randomized controlled trial that the addition of pixantrone to rituximab significantly increased median time to progression over rituximab alone in relapsed indolent non-Hodgkin’s lymphoma patients. That data, coupled with the marked increase in progression-free survival when pixantrone was added to a fludarabine-based regimen, provides a strong rationale for proceeding with this trial which could expand the application into the larger indolent non-Hodgkin’s lymphoma market.”