ALLOS INITIATES TRIAL OF PDX IN LYMPHOMA PATIENTS
Allos Therapeutics has enrolled the first patient in PROPEL, a multicenter Phase II study of the company's next-generation antifolate, PDX (pralatrexate), with vitamin B12 and folic acid supplementation in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
PROPEL (Pralatrexate in Patients with Relapsed Or Refractory PEripheral T-cell Lymphoma) is a Phase II, international, open-label, single-arm study that will seek to enroll 100 patients with relapsed or refractory PTCL 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 company announced in August that it reached agreement with the FDA under the special protocol assessment (SPA) process on the design of this pivotal Phase II trial. The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a new drug application, and provides a binding agreement that the study design, including trial size, clinical endpoints and/or data analyses, are acceptable to the FDA.
The company anticipates that patient enrollment at 35 centers in the U.S., Canada and Europe will take approximately 18 to 24 months to complete.
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