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news.Allos Therapeutics has completed patient enrollment in Propel, the company's pivotal Phase II trial of PDX in patients with relapsed or refractory peripheral T-cell lymphoma.
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Propel is a pivotal Phase II, international, multi-center, open-label, single-arm study that enrolled patients with relapsed or refractory PTCL who 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 treatment regimen also includes vitamin B12 and folic acid supplementation.
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.
Pablo Cagnoni, chief medical officer of Allos, said: “We believe that PDX has the potential to offer a new treatment option for patients with this challenging disease and look forward to reporting top line results of the trial later this year.”