To observe the safety, tolerability and clinical effects of PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.
Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. The investigators have been proceeding this trial to evaluate the efficacy and safety of the PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
100
PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Gemcitabine is a cytosine nucleoside derivative, its main metabolite incorporates into DNA in cells and mainly acts on G1 / S phase.
Oncology Department of The First Affilliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGOverall Response Rate
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation.
Time frame: From date of randomization until the date tumor volume has reduced, assessed up to 36 months
Progression-free Survival
The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Overall Survival
Time from randomization to death for any reason
Time frame: From date of randomization until date of death from any cause, assessed up to 36 months
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