Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05676710 | Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia | PHASE1 | COMPLETED | 8 | — | — | Feb 10, 2023 | Feb 14, 2024 | May 29, 2024 | 2 | China |
Percentage of patients with hematological response. Hematological response is evaluated by hemoglobin (Hb), absolute neutrophil count (ANC), platelet count (PLT), absolute lymphocyte count (ALC), absolute large granular lymphocyte count, and blood transfusion.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | PI3K inhibitors |
| Name | Type | Description |
|---|---|---|
| Linperlisib | DRUG | Elevated PI3K activity in T-LGL likely plays an important role in the ability of the pathologic cells to avoid homeostatic apoptosis, since inhibition of this pathway leads to apoptosis in the population of cells harboring the pathologic clone. More importantly, the activity of this pathway may represent a kind of "Achilles heel" for T-LGL in that PI3K inhibitors alone are quite effective at inducing spontaneous apoptosis in the clonal CTLs after a short incubation. |
Inclusion Criteria: * Male or female age ≥ 18 years * Diagnosis of T-cell large granular lymphocytic leukemia (T-LGLL) * Meet any of the following indications for treatment： 1. Hemoglobin \< 100g/L or RBC transfusion dependence 2. Neutrophil count \<0.5×10\^9/L or neutrophil count decreased wi...