Clinical Trial: CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation

Brief Summary: Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation

Detailed Summary: Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v.
Sponsor: University of Göttingen

Current Primary Outcome: Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy [ Time Frame: average of 24 weeks (treatment duration) ]

A descriptive approach for the primary endpoint was chosen: Adherence to schedule of alemtuzumab consolidation (number of cycles, dosing, time) - comparison of planned vs given in pts receiving alemtuzumab


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • rate of complete remissions [ Time Frame: at week 24 after initiation ]
  • Overall survival [ Time Frame: 5 years ]


Original Secondary Outcome: Same as current

Information By: University of Göttingen

Dates:
Date Received: February 25, 2013
Date Started: July 2003
Date Completion:
Last Updated: March 6, 2013
Last Verified: March 2013