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| Name | Class |
|---|---|
| YL-Pharma | UNKNOWN |
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This is a prospective, multicenter, single-arm, pilot study. The aim of this study is to evaluate the efficacy and safety of linperlisib, the PI3K delta inhibitor for patients with relapsed/refractory large granular T lymphocytic leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | PI3K inhibitors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate: HPR + HCR + CMR | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the adverse event | Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event | 8 weeks |
| Time to achieve partial hematologic response (HPR) | Duration time was calculated from enrollment to achieve HPR. HPR is assessed by Hb, ANC, PLT, ALC, absolute large granular lymphocyte count and blood transfusion |
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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:
Failure or intolerance to a first-line therapy
ECOG performance status ≤2
Expected survival ≥ 6 months
Willing and able to comply with the requirements for this study and written informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhoukou Central Hospital | Zhoukou | Henan | China | |||
| Regenerative Medicine Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40147444 | Derived | Zhang L, Qiu C, Li R, Shen Y, Tian L, Chang H, Liang Q, Pan H, Gao Z, Li W, Zhao J, Fang L, Yu X, Xu J, Kuang Z, Yuan W, Chu Y, Shi J. KLRG1 re-defines a leukemic clone of CD8 effector T cells sensitive to PI3K inhibitor in T cell large granular lymphocytic leukemia. Cell Rep Med. 2025 Apr 15;6(4):102036. doi: 10.1016/j.xcrm.2025.102036. Epub 2025 Mar 26. |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 8 weeks |
| Time to achieve complete hematologic response (HCR) | Duration time was calculated from enrollment to achieve HCR. HCR is assessed by Hb, ANC, PLT, ALC, and absolute large granular lymphocyte count. | 8 weeks |
| Time to achieve complete molecular response (CMR) | Duration time was calculated from enrollment to achieve CMR. CMR is assessed by Hb, ANC, PLT, ALC, and absolute large granular lymphocyte count | 8 weeks |
| Change of the health-related quality of life | Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) is used to assess the health-related quality of life of patients. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability | Baseline and 2 cycles of therapy |
| Relapse free survival (RFS) | Duration time was calculated from response to relapse. | A minimum of 2 years of planned follow-up |
| Tianjin |
| Tianjin Municipality |
| China |