Efficacy and Safety of Linperlisib in Relapsed/Refractory Large Granular T Lymphocytic Leukemia

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jan 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Linperlisib, which is designed to help patients with a type of blood cancer known as relapsed or refractory large granular T lymphocytic leukemia (T-LGLL). The goal is to see how effective and safe Linperlisib is for people whose cancer has not responded to previous treatments or who cannot tolerate those treatments. The trial is currently recruiting participants aged 18 and older who meet specific health criteria, such as having low blood cell counts or significant symptoms from their leukemia.

If you decide to participate, you will receive Linperlisib and be monitored for how well it works and any side effects you might experience. It's important to know that certain health conditions may exclude you from joining, such as having a recent serious infection or other significant illnesses. Additionally, you will need to provide written consent and be willing to follow the study's requirements. This trial offers hope for patients looking for new treatment options for their condition.

Gender

ALL

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