Diffuse Large B-cell Lymphoma
Conditions
Interventions
Experimental group:PI3K inhibitor in combination with RCHOP regimen.
Sponsors
The First Affiliated Hospital of Zhejiang University Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Diagnosed histopathologically as CD20-positive, previously untreated diffuse large B-cell lymphoma. 2) At least one measurable lesion on imaging. 3) Age between 18 and 60 years old at enrollment, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 4) Inclusion criteria include meeting at least one of the following: (1) Tumor mass with the longest diameter = 10 cm by CT or PET/CT evaluation; (2) International Prognostic Index (IPI) score = 2; (3) Involvement of more than 2 extranodal sites; (4) Known adverse prognostic genetic or molecular abnormalities, such as P53 gene mutation, MYD88/CD79B mutation, c-MYC/BCL2 double expression, c-MYC/BCL-2/BCL-6 triple-hit, or double-hit. 5) Informed consent signed by the patient or their guardian. 6) Expected survival of at least 3 months.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women, and reproductive-aged patients unwilling to use contraception. 2) Abnormal liver function (total bilirubin > 1.5 times the upper limit of normal, ALT/AST > 2.5 times the upper limit of normal, or ALT/AST > 5 times the upper limit of normal in patients with liver involvement), or abnormal kidney function (serum creatinine > 1.5 times the upper limit of normal). 3) Neutrophil absolute count 480 ms; B. Complete left bundle branch block, II or III degree atrioventricular block; C. Severe, uncontrolled arrhythmias requiring medication; D. New York Heart Association (NYHA) class = III; E. Left ventricular ejection fraction (LVEF) less than 50%; F. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias within 6 months prior to recruitment, or any other clinically significant history of arrhythmias, or evidence of acute ischemic or active conduction abnormalities on electrocardiography; G. Baseline NT-proBNP greater than 800 pg/mL, cTnI greater than the upper limit of normal for this center, with repeat testing after three days still exceeding the above ranges. 6) Patients with psychiatric disorders/unable to obtain informed consent. 7) Received chemotherapy for other malignancies within three weeks prior to enrollment. 8) History of immunodeficiency, including HIV positive testing, or having other acquired or congenital immunodeficiency diseases. 9) Known HBV, HCV infection (if either hepatitis B surface antigen or core antibody is positive, HBV DNA is tested, excluding those with HBV DNA exceeding 1x10^3 copies/mL; if HCV antibody is positive, HCV RNA is tested, excluding those with HCV RNA exceeding 1x10^3 copies/mL), untreated syphilis-positive individuals, and active tuberculosis patients. 10) History of previous lymphoma, treated with PI3K inhibitors. 11) Presence of primary or secondary central nervous system lymphoma or history of central nervous system lymphoma at recruitment. 12) Pregnant or lactating women, and reproductive-aged patients unwilling to use contraception. 13) Other situations where the investigator deems the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II recommended dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| maximum tolerated dose;dose-limiting toxicity;Hematologic and non-hematologic adverse events;Objective response rate;Complete response rate;Duration of response;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactHongyan Tong
The first affiliated hospital, Zhejiang University school of medicine
Outcome results
None listed