Table of contents
- Trial overview
- Who is being studied
- Trial phases and study design
- What researchers measure
- Key trials that include Idelalisib
- Patient-friendly terms
Trial overview
The trial data show that Idelalisib is being used in research mainly for people with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).[1][2][3] In these studies, Idelalisib is not the only treatment being tested; it is part of a treatment choice that is compared with newer study drugs or other allowed regimens.[1][2][3]
One additional study in this set is in colorectal cancer, but it does not focus on Idelalisib alone and is mainly about finding the best treatment matched to tumor testing.[4] Because the request is about trials investigating Idelalisib, the blood cancer studies are the most important ones here.[1][2][3]
Who is being studied
The main target group is people with CLL/SLL, including patients who have already been treated before and now need another option.[2][3] One study specifically includes patients with disease that is relapsed/refractory, which means the cancer came back or did not respond well to earlier treatment.[3]
Another study includes patients with CLL or SLL who were previously exposed to both BTK and BCL2 inhibitors, meaning they already received certain earlier targeted treatments before joining the trial.[1] This shows that the studies are looking at people with more advanced treatment history, not newly diagnosed patients.[1][2][3]
Trial phases and study design
All of the Idelalisib-related CLL/SLL studies in this data set are Phase 3 trials.[1][2][3] Phase 3 trials are larger studies that compare treatment options and help show which one works better or more reliably.[1][2][3]
These studies are interventional, which means the researchers assign a treatment plan and then follow patient outcomes.[1][2][3] Two of the studies are randomized and compare a new study drug against investigator’s choice, where the study team selects from allowed treatment options.[1][2]
What researchers measure
The most common main outcome is progression-free survival (PFS), which means the time from randomization until the disease gets worse or the patient dies, whichever happens first.[1][2][3] In these trials, PFS is checked by an Independent Review Committee (IRC), a separate group that reviews the results in a standard way.[1][2][3]
One study also measures objective response rate (ORR), which means how many patients have a confirmed complete response or partial response.[4] A complete response means no signs of disease can be found, while a partial response means the disease has shrunk.[4]
Key trials that include Idelalisib
NCT04666038 is a Phase 3 open-label randomized study in BTK inhibitor-pretreated CLL/SLL.[2] It compares pirtobrutinib with investigator’s choice of Idelalisib plus rituximab or bendamustine plus rituximab, and the main outcome is PFS by IRC review.[2]
2024-518893-15-00 is a Phase 3 study in CLL or SLL previously exposed to both BTK and BCL2 inhibitors.[1] It compares BGB-16673 with investigator’s choice, which can include Idelalisib plus rituximab, bendamustine plus rituximab, or venetoclax plus rituximab retreatment, and the main endpoint is PFS.[1]
2025-522669-32-00 is a Phase 3 study in relapsed/refractory CLL/SLL.[3] It compares DZD8586 with investigator’s choice, and the main outcome is PFS assessed by IRC using standard CLL/SLL review rules.[3]
NCT05725200 is a Phase 2 colorectal cancer study called EVIDENT.[4] It looks at tumor testing, organoid creation, and objective response rate for matched treatments, and it lists Zydelig among many drugs in the study supply, but the main study focus is colorectal cancer rather than Idelalisib-specific testing.[4]
Patient-friendly terms
- Randomization means patients are placed into study groups by chance, so the comparison is fair.[2]
- Open-label means both the study team and the patient know which treatment is being given.[2]
- Rituximab and bendamustine are treatment options used in the comparison groups in some trials.[1][2]
- Venetoclax retreatment means using venetoclax again in patients who already had it before, as listed in one study’s choice of treatment.[1]
- Organoids are small lab-grown models made from tumor tissue, used in the colorectal cancer study to help match treatment choices.[4]
