Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy
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
average of 24 weeks (treatment duration)
Yes
Lorenz Truemper
Principal Investigator
German High Grade Non Hodgkin´s Lymphoma Study Group
Germany: Paul-Ehrlich-Institut
DSHNHL-2003-1
NCT01806337
July 2003
February 2011
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