The prognosis of DLBCL with MYC rearrangement is dismal. Previous study showed that lenalidomide in combination with R-CHOP showed promising therapeutic activity and that R-DA EPOCH was superior compared to R-CHOP regimen in this cohort of patients. The investigators therefore design this phase I/II study to investigate the safety and efficacy of lenalidomide in combination with R-DA EPOCH in patients with untreated MYC-rearranged DLBCL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle
Rituximab 375 mg/m2,IV, d0
Etoposide 50 mg/m2/day CI24h d1-d4
Doxorubicin 10 mg/m2/day CI24h d1-d4
Vincristine 0.4mg/m2/day CI24h d1-d4
Cyclophosphamide 750 mg/m2/day IV d5
Prednisone 60 mg/m2/bid oral or IV d1-d5
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China
RECRUITINGmaximum tolerated dose and dose limited toxicity
Time frame: 21 days after first cycle of R2-DA-EPOCH regimen (each cycle is 21 days)
Overall response rate
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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