The prognosis of PTCL (except early stage ALK+ ALCL) is dismal. Previous study showed that single agent lenalidomide showed promising therapeutic activity in patients with relapsed or refractory PTCL. The investigators therefore design this phase II study to investigate the safety and efficacy of lenalidomide in combination with CHOP in patients with treatment-naive PTCL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle
Cyclophosphamide 750 mg/m2 d1
Doxorubicin 50 mg/m2 d1
Vincristine 1.4mg/m2 (maximum 2mg) d1
Prednisolone 60mg/m2 d1-5
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China
RECRUITINGmaximum tolerated dose and dose limited toxicity
Time frame: At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days)
Overall response rate
overall response rate after treated by lenalidomide-CHOP regimen
Time frame: 6 months
Progressive free survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame: 2 years
Overall survival
from the date of inclusion to date of death, irrespective of cause
Time frame: 2 years
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