This is a prospective, single arm, single center study to evaluate the efficacy and safety of Duvelisib combined with Chidamide in the treatment of newly diagnosed peripheral T-cell lymphoma.
This is a prospective, single arm, single center study, including two phases. It plans to recruit36 patients with clinically diagnosed primary PTCL who will be treated with Duvelisib and Chidamide. In the first phase Duvelisib is Oral administration at a dose of 25mg twice a day, and every 4 weeks (28 days) was a cycle. Next administration will be depend on whether the efficacy reaches CR in the second phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGSafety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
To identify the incidence of AE and SAE in clinical trial
Time frame: from the initiation of the first dose to 28 days after the last dose
Objective response rate (ORR)
To evaluate the efficacy of anti-lymphoma
Time frame: up to 26 weeks
Complete remission rate (CR)
To evaluate the efficacy of anti-lymphoma
Time frame: up to 26 weeks
Duration of Response（DOR）
To evaluate the efficacy of anti-lymphoma
Time frame: The time from the first assessment as CR or PR to the first assessment as PD or death (due to any cause)，assessed up to 12 months
Progression free survival (PFS)
To evaluate the efficacy of anti-lymphoma
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 20 months
Overall survival (OS)
To evaluate the efficacy of anti-lymphoma
Time frame: From date of randomization until the date of death from any cause, assessed up to 20 months
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