Allos initiates phase II lymphoma study

“The initiation of this pivotal trial is an important milestone in the development of PDX and has the potential to be a significant driver of the company’s future growth,” said Paul Berns, president and CEO. “Clinical experience to date suggests that PDX has the potential to provide meaningful therapeutic benefit to a difficult to treat, drug resistant patient population with high unmet medical need.”

The trial, named PROPEL, is a phase II, international, multi-center, open-label, single-arm study that will seek to enroll 100 evaluable patients with relapsed or refractory peripheral T-cell lymphoma who have progressed after at least one prior treatment. Patients will receive 30 mg/m2 of PDX once every week for six weeks followed by one week of rest per cycle of treatment.

The primary endpoint of the study is objective response rate (complete and partial response). Secondary endpoints include duration of response, progression-free survival and overall survival.

The trial was designed under a special protocol assessment with the FDA.