A National Multicenter, Real-world Study of Linperlisib in the Treatment of Lymphoma

Trial Title: A National Multicenter, Real-world Study of Linperlisib in the Treatment of Lymphoma

NCT ID: NCT06343935

Condition: Indolent B-cell Lymphoma

Conditions: Official terms:
Lymphoma

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Linperlisib
Description: Linperlisib is a small molecule inhibitor of phosphoinositol 3-kinase-δ (PI3K-δ)
Arm group label: Treatment group(linperlisib 80mg qd)
Arm group label: control group(linperlisib 80mg 14d-on 7d-off)

Other name: YY-20394

Summary: This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. The aim is to evaluate the efficacy and safety of linperlisib in the treatment of patients with relapsed/refractory indolent B-cell lymphoma at two doses/modes of administration (clinically recommended dose/mode and optimized dose/mode).

Detailed description: This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. The aim is to evaluate the efficacy and safety of linperlisib in the treatment of patients with relapsed/refractory indolent B-cell lymphoma at two doses/modes of administration (clinically recommended dose/mode and optimized dose/mode). Patients were divided to two groups by stratified randomization according to tumor type (FL, CLL/SLL, MZL, others) during the screening period. Both groups were orally administered with a starting dose of 80mg qd for 21 days. On the 21st day of the 4th cycle, if the patient's tumor does not progress and there is no intolerable toxicity, after the researchers determined that medication could be continued, one group of patients continued to take 80mg qd dose continuously, and the other group of patients continued to take 80mg qd dose continuously for two weeks per cycle and stopped for one week, and safety and tumor efficacy evaluation were conducted regularly. The maximum duration of treatment is two years until the disease progresses, toxicity becomes intolerable, or the investigator determines that it is not appropriate to continue treatment.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Patients with r/r indolent B-cell lymphoma confirmed by histology or cytology, mainly follicular lymphoma (FL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma (MZL), and lymphoplasmacytic lymphoma/macroglobulinemia (LPL/WM), 2. ECOG performance status (PS) 0 ~ 2 points, 3. Expected survival ≥3 months, 5) At least one measurable lesion was present in patients other than CLL, LPL/WM; 6) Good organ function level, 7) The elution period from the end of previous anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, surgery or molecular targeted therapy) to participation in this trial is ≥4 weeks, in which the elution period of small-molecule targeted drugs and Chinese medicines with anti-tumor effects is ≥14 days. Exclusion Criteria: 1. Those who have progressed with antitumor drugs targeting PI3Kδ (except for those who cannot tolerate them), 2. There is a third space effusion (such as a large amount of pleural fluid and ascites) that the investigators judge to be uncontrollable, 3. Steroid hormone dosage (equivalent amount of prednisone) was greater than 20mg/ day for 4 weeks before enrollment, and continuous use was more than 14 days, 4. Inability to swallow, chronic diarrhea or intestinal obstruction, there are multiple factors that affect drug use and absorption, 5. Allergic constitution, or known allergic history of the drug components, 6. Patients with active viral, bacterial or fungal infections (such as pneumonia) within 4 weeks prior to enrollment; Or had uncontrolled pulmonary fibrosis, acute lung disease, or interstitial lung disease within 4 weeks prior to enrollment, 7. Infected with HBV and HCV, 8. History of immune deficiency, 9. Moderate or severe heart disease, 10. Have undergone major surgery within 28 days before signing informed consent, or plan to undergo major surgery during the study period, 11. The first study of patients with a history of other malignancies within 5 years prior to drug administration (except for patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other cancers in situ without disease recurrence within 2 years), 12. Received autologous hematopoietic stem cell transplantation within 90 days before the first medication,

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: April 30, 2024

Completion date: April 30, 2025

Lead sponsor:
Agency: Shanghai YingLi Pharmaceutical Co. Ltd.
Agency class: Industry

Source: Shanghai YingLi Pharmaceutical Co. Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06343935