Linperlisib Combined With EZH2 Inhibitor in Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)

Linperlisib doses were preset at 40mg QD and 60mg QD, while SHR2554 doses were preset at 150mg BID, 200mg BID, and 300mg BID, forming six dose groups in total. The BOIN Waterfall design was employed to divide these six groups into two sub-trials. Initially, three participants will be recruited into the lowest dose group of the first sub-trial: Linperlisib (40mg QD) and SHR2554 (150mg BID). After completing the dose-limiting toxicity (DLT) observation period, the next dose group will begin. Once DLT evaluations for the three participants are completed, the statistician will review the safety data and, following the decision-making flowchart of the BOIN design, determine whether to escalate to the next dose level. Another three participants will be enrolled and evaluated, continuing this process until all dose combinations in the first sub-trial have been tested, the sample size is depleted, or a stopping rule is triggered. Based on the results of the first sub-trial, the statistician will assess and select the starting dose for the second sub-trial, repeating the process until the trial is complete.