Peripheral T-cell Lymphomas Clinical Trial
Official title:
The Efficacy and Safety Research of Endostar Combined With GDP to Treat Aggressive Peripheral T-cell Lymphoma (PTCL) in Phase II Clinical Study.
The aim of this study is to evaluate anti-tumor safety and efficacy of endostar®（Human recombinant endostatin injection）combined with traditional GDP （gemcitabine+dexamethasone+cis-platinum）chemotherapy for newly diagnosed or relapsed PTCL(aggressive peripheral T-cell lymphomas) patients in phase II clinical study.
Endostar is a conventional drug for treatment of advanced non-small cell lung cancer,
nowadays,Endostar has been used in a variety of extra-pulmonary tumor treatment in
clinical.Some basic experiments and clinical researchs confirm that Endostar can restitute
the tumor stability after cyclophosphamide or rituximab treatment.
The aim of this study is to evaluate anti-tumor safety and efficacy of endostar for newly
diagnosed or relapsed PTCL patients based on chemotherapy combined with conventional
GDP.This is a multi-center, open, randomized-controlled, phase II clinical study.
Following a run-in period, approximately 60 subjects will be randomly assigned to
conventional chemotherapy treatment group, endostar and conventional chemotherapy treatment
group for 1 year. After the 1 year treatment period, subjects in two treatments arms will be
followed for 1 year.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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