This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Patients will receive six cycles of induction therapy of linperlisib in combination with CHOP regimen. All patients with CR and PR after induction therapy receive linperlisib maintenance therapy every 28 days until disease progression or other reasons lead to discontinuation, and the duration of linperlisib maintenance does not exceed 24 months.
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
Dose-limiting toxicity (DLT, Phase Ib)
To identify the DLT
Time frame: The first cycle of linperlisib in combination with R-CHOP regimen (21 days)
Complete remission rate (CR rate) based on the 2014 Lugano evaluation criteria (Phase II)
To investigate the antitumor efficacy
Time frame: Up to 18 weeks
Overall response rate (ORR)
To investigate the antitumor efficacy
Time frame: Up to 18 weeks
Duration of complete remission
To investigate the antitumor efficacy
Time frame: From date of complete remission to the study treatment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Duration of remission (DOR)
To investigate the antitumor efficacy
Time frame: From date of remission to the study treatment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression free survival (PFS)
To investigate the antitumor efficacy
Time frame: From date of the first injection until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival (OS)
To investigate the antitumor efficacy
Time frame: From date of the first injection until the date of death from ant cause, assessed up to 24 months
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Incidence and severity of adverse events (AE) and Serious adverse event (SAE), as well as abnormal laboratory inspection indicators; Quality of Life (QOL).
To identify the incidence of AE, SAE and QOL.
Time frame: Through study completion, an average of 2 years