Efficacy and Safety of Linperlisib in Relapsed/Refractory... | NCT06224257

NCT06224257

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Name	Class
YL-Pharma	UNKNOWN

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Linperlisib	Experimental	Linperlisib was administered at 80 mg every day, orally in a 28-day cycle until disease progression or intolerable toxicity occurred.	Drug: Linperlisib

Interventions

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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with hematologic remission	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.	8-12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Incidence of the adverse event	Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event	8-12 weeks

Eligibility Module

Eligibility Criteria

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 with recurrent infection 3. Progressive splenomegaly and/or Massive Splenomegaly 4. Combined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc. 5. Severe B symptoms
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:

History of other lymphoproliferative neoplasms
Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors
Previously received organ or stem cell transplantation
Patients with active infection within 2 weeks before giving the first dose of medication
Patients with HBV, HCV, HIV or other infections that require treatment
History of immunodeficiency, or congenital immunodeficiency disorders
Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract.
Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values
Renal impairment: creatinine clearance <30ml/min
History of mental illness
History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.
Received attenuated vaccine 4 in weeks before enrollment
Participation in another clinical trial within 4 weeks before the start of this trial
Have an allergy to Linperlisib or any other part of this medicine.
Pregnant or breast-feeding patients
Patients considered to be ineligible for the study by the investigator for reasons other than the above

Name	Role	Phone	Extension	Email
Jun Shi, PhD	Contact	13752253515		shijun@ihcams.ac.cn
Lele Zhang, PhD	Contact	15811139278		zhanglele@ihcams.ac.cn

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms