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. 2026 Oct 14;3(1):e20260040. doi: 10.70962/jhi.20260040

Figure 1.

A flowchart of a clinical study design and patient enrollment. The flowchart starts with a dose-finding trial (DFT) involving 6 patients who received leniolisib. These patients did not participate in the subsequent randomized placebo-controlled trial (RCT), which included 21 patients on leniolisib and 10 on placebo. All 6 patients from the DFT and 20 from the leniolisib arm and 9 from the placebo arm of the RCT enrolled in the open-label extension (OLE). Additionally, 2 new patients who previously received phosphoinositide 3-kinase delta inhibitors in other studies joined the OLE. The OLE study involved 37 participants in total.

Study design and patient enrollment. Six patients received leniolisib during the initial DFT. These six patients did not take part in the randomized placebo-controlled trial, which included 21 patients in the leniolisib arm and 10 in the placebo arm. All six patients from the DFT enrolled in the OLE. 20 patients from the leniolisib arm and 9 from the placebo arm rolled into the OLE. Additionally, two new patients who previously received PI3Kδ inhibitors in other clinical studies enrolled in the OLE. bid, twice daily; FPFV, first patient first visit; LPFV, last patient first visit; RCT, randomized placebo-controlled trial.