Novel Treatments Demonstrate Improvements in Overall Survival and Response Rates in Difficult-To-Treat Forms of Leukemia an...(cumulative incidence for death in the in...),Health

Date:12/6/2008

cumulative incidence for death in the induction phase was 2 percent for dexamethasone compared with 0.9 percent for prednisone; however, the cumulative incidence of death during remission was similar between the two treatment groups (2 percent for dexamethasone and 1.6 for prednisone).

PROPEL: A MulticenterPhase II Open-Label Study of Pralatrexate (PDX) With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Peripheral T-CellLymphoma

[Abstract #261]

Owen A. O'Connor, M.D., Ph.D., Columbia UniversityMedical Center, New York, NY

This study, the largest prospective clinical trial in patients with relapsed or refractory peripheral T-cell lymphoma, found that the investigational chemotherapy agent pralatrexate produces complete responses (disappearance of all signs of cancer) in patients who had previously failed an average of three treatment regimens, including an autologous stem cell transplant for some patients. Designed to be selectively transported into tumor cells, the novel antifolate pralatrexate accumulates to high concentrations in the tumor cell, inhibiting DNA synthesis.

A total of 115 patients were enrolled into this phase II, single-arm, non-randomized, open-label study and received weekly intraveneous infusions of pralatrexate (30 mg/m^2) for seven weeks. All patients also received vitamin B12 and folic acid throughout the study in order to prevent potential side effects of the pralatrexate. The primary endpoint of the study was the objective response rate, including all patients who had some response of their disease to therapy. Secondary endpoints included duration of response, progression-free survival, and overall survival.

Interim data of the first 65 evaluable patients showed that 29 percent
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SOURCE American Society of Hematology Copyright©2008 PR Newswire. All rights reserved

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