This is a single-arm, multicenter, Phase Ib/IIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). The study is divided into a Phase Ib safety lead-in phase and a Phase IIa dose expansion phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Patients will receive 6 cycles of SHR2554 combined with liposomal mitoxantrone as induction therapy. All patients who achieve a complete response (CR) after induction therapy are eligible for transplantation. Patients achieving CR or partial response (PR), as well as those post-transplantation, may receive SHR2554 maintenance therapy in 28-day cycles. Maintenance therapy will continue until disease progression or other reasons for discontinuation. The maximum duration of SHR2554 administration in the maintenance phase will not exceed 24 months.
Incidence of Dose-Limiting Toxicities (DLT)
Adverse events (AE) defined as DLT events per protocol
Time frame: Cycle 1 (28 days)
Complete response (CR) rate
The proportion of subjects evaluated as complete response (CR) according to Lugano 2014 efficacy evaluation criteria
Time frame: up to 6 months after enrollment
Objective response rate (ORR)
The proportion of subjects evaluated as complete response (CR) and partial response (PR) according to Lugano 2014 efficacy evaluation criteria
Time frame: up to 6 months after enrollment
Duration of Response (DOR)
The time from the first assessment of CR/PR to the first assessment of PD or death from any cause in the subject
Time frame: up to 2.5 years post first treatment
Duration of complete response (CR)
The time from the first assessment of CR to the first assessment of PD or death from any cause in the subject
Time frame: up to 2.5 years post first treatment
Progression-free Survival (PFS)
From the time subjects were enrolled to the time of disease progression (in any way) or death from any cause.
Time frame: Up to 2.5 years
Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause.
Time frame: Up to 2.5 years
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Adverse events(AE)
The safety of the drug was evaluated by NCI-CTC AE 6.0 standard. Hematologic and non-hematologic toxicity.
Time frame: From the first day of medication to 28 days after the last dose