Cell Therapeutics, Inc. has announced that it has initiated its randomized pivotal trial of pixantrone for the treatment of relapsed/refractory diffuse large B-cell lymphoma. The clinical trial is now open to patient enrollment. The trial, referred to as the PIX-R or PIX 306 trial, will compare a combination of pixantrone plus rituximab to a combination of gemcitabine plus rituximab in patients with relapsed or refractory DLBCL who have received one to three prior lines of therapy.
The PIX-R trial utilizes progression free survival and overall survival as co-primary endpoints of the study. The PIX-R trial is targeting to enroll approximately 350 patients over 18 months and will include patients who have failed at least one line of previous therapy and patients who are not candidates for myeloablative chemotherapy and stem cell transplant.
"We are pleased to open enrollment for this study and have been in communication with leading cancer clinical sites that are enthusiastic about participating in the study largely based on the positive results of our previous study, PIX301, in relapsed/refractory aggressive non-Hodgkin's lymphoma patients," said Jack W. Singer, M.D., Chief Medical Officer of CTI. "There is an unmet medical need in this patient group, and the lack of any FDA approved drug for these patients should generate strong interest in the trial from both the patients and physicians."
For more information on the PIX-R trial, investigators and patients can visit www.pixrtrial.com. CTI expects the PIX-R trial to be posted to www.clinicaltrials.gov in the near future. CTI expects to have 60 sites open for enrollment by the end of April 2011.
The PIX-R trial may serve as either a post-marketing commitment trial or as a follow-on pivotal trial depending on the outcome of a formal appeal that CTI submitted to the Food & Drug Administration's Office of New Drugs in the FDA's Center for Drug Evaluation and Research in December 2010 regarding its 2010 decision about CTI's new drug application for pixantrone.
The NDA for pixantrone was based on the results of the PIX 301 trial, a randomized trial comparing pixantrone as monotherapy to a choice of standard single-agent chemotherapy in relapsed/refractory aggressive non-Hodgkin's lymphoma patients. CTI expects a decision regarding its appeal in the second quarter of 2011.