A Special Protocol Assessment (SPA) has been submitted by Cell Therapeutics, Inc. (Nasdaq: CTIC) to the U.S. Food and Drug Administration (FDA) for the design of its phase III trial of pixantrone for patients with indolent non- Hodgkin's lymphoma (NHL).
The said trial, expecting to enroll 300 patients, will evaluate the complete remission rates and time to disease progression of the combination regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have failed up to five prior treatments for relapsed or refractory indolent NHL.
Pixantrone was developed to improve the activity and safety of the anthracycline family of anti-cancer agents – which has been associated to cardiotoxicities.
Currently, pixantrone is being investigated for the potential treatment of various hematological malignancies, solid tumors and immunological disorders.
Find more details from the press release.
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