Cell Therapeutics announced that it has initiated its trial of pixantrone for the treatment of relapsed/refractory diffuse large B-cell lymphoma (“DLBCL”). The clinical trial is now open to patient enrollment. The trial, referred to as the PIX-R or PIX 306, is designed to be a randomized, multicenter study comparing pixantrone + rituximab to gemcitabine + rituximab in patients with relapsed or refractory DLBCL or DLBCL transformed from follicular lymphoma who have received one to three prior lines of therapy, including CHOP-R or an equivalent regimen.
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.
Pixantrone is a aza-anthracenedione that inhibits Topo-isomerase II, alkylates DNA and forms stable DNA adducts with particular specificity for CpG rich, hyper-methylated sites.
For more information visit www.pixrtrial.com.