Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in R/R NHL (NCT07195799) | Clinical Trial Compass
RecruitingPhase 2
Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in R/R NHL
China180 participantsStarted 2024-12-31
Plain-language summary
This is a multicenter, open-label, non-randomized, multi-cohort study to evaluate the efficacy and safety of linperlisib combined with cyclophosphamide, prednisone, and thalidomide (CPT) regimen in the treatment of relapsed and/or refractory non-Hodgkin lymphoma.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Male or female, β₯18 years old;
β. Histologically confirmed diagnosis of FL/PTCL/NKTCL/CLL /MZL/MCL;
β. Except for CLL (using the 2018 iwCLL criteria), patients must have at least one measurable lesion/evaluable lesion that meets the 2014 version of Lugano lymphoma evaluation criteria;
β. FL patients:
β. Have previously received at least one-line systemic treatment, have disease progression during or after the most recent treatment, or confirmed no objective response with adequate treatment;
β. Includes the following subtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCLοΌEATL; patients with ALCL must have previously received CD30-targeted therapy or be ineligible for CD30-targeted therapy; 6. NK/TCL patients:
β. Have measurable lesions (peripheral blood B lymphocytes β₯5Γ10\^9/L, or enlarged lymph node (baseline LDi β₯ 1.5cm), or hepatomegaly or splenomegaly due to CLL);
β. Patients with resistance or intolerance following prior first-line or above therapy (regiments containing BTK inhibitors or BCL-2 inhibitors);
Exclusion criteria
β. Had been progressed on PI3K inhibitor before enrollment;
β. Any other anti-tumor therapy within 4 weeks;
β. The presence of third-space effusion (e.g., massive pleural effusion and ascites) that could not be controlled by drainage or other methods;
What they're measuring
1
Best Objective Response Rate
Timeframe: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
Trial details
NCT IDNCT07195799
SponsorThe First Affiliated Hospital with Nanjing Medical University
β. Involvement of the central nervous system (meninges or brain parenchyma);
β. Long-term use of corticosteroids exceeding 30mg/day of prednisone or its equivalent;
β. Inability to swallow, chronic diarrhea or intestinal obstruction, or other factors affecting drug intake and absorption;
β. Individuals with a history of allergies or known hypersensitivity to any component of the regimen;
β. A history of any cardiac disease, including: (1) angina; (2) arrhythmias requiring clinical intervention; (3) myocardial infarction; (4) heart failure; (5) any other cardiac conditions deemed unsuitable for participation in this trial by the investigator;