This is a prospective, single-center, open-label clinical study designed to evaluate the efficacy and safety of the Zanubrutinib, Lenalidomide and Rituximab (ZR2) versus rituximab combined with CHOP or CDOP (R-CHOP or R-CDOP) in elderly patients with diffuse large B cell lymphoma treated for the first time.
In this study, elderly DLBCL patients will be treated with ZR2 regimen for the first-line treatment. Investigators will compare the complete response rate, survival and incidence of adverse reactions between the RCHOP/RCDOP chemotherapy and the ZR2 regimen. In addition, immune function tests will be performed before treatment and every 2 courses after treatment, including peripheral blood lymphocyte-monocyte ratio, cytokines, immunoglobulins, T and B cells and their quantitative analysis. Patients with ZR2 regimen will undergo gene second-generation sequencing before treatment to compare the gene mutation differences between complete response (CR) and ≤ partial response (PR) in the efficacy of ZR2 regimen, in order to find biomarkers with better efficacy in ZR2 treatment. Moreover, investigators intend to conduct pharmacokinetics/pharmacodynamics (PK/PD) correlation analysis of ZR2 regimen and pharmacoeconomic evaluation of the two regimens.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Zanubrutinib is a bruton' s tyrosine kinase inhibitor independently developed in China.
RCHOP/RCDOP is the classic treatment of diffuse large B cell lymphoma.
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGComplete response rate
Percentage of participants with complete response is determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).
Overall survival
Overall survival is defined as the time from the date of randomization to the date of death from any cause.
Time frame: Baseline up to data cut-off (up to approximately 3 years).
Progression free survival
Progression-free survival is defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame: Baseline up to data cut-off (up to approximately 3 years).
Incidence rate of adverse events
Percentage of participants with treatment-related adverse events is assessed by CTCAEv4.0.
Time frame: From enrollment to study completion, a maximum of 3 years.
Direct medical costs
Direct medical costs include personal expenses and medical insurance reimbursement expenses, mainly including examination expenses, disposal expenses, medical expenses, hospitalization expenses, and other expenses.
Time frame: At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).
EQ-5D scores
EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) is calculated for the pharmacoeconomics analysis to evaluate the quality of life in participants. EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.
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Time frame: At the end of Cycle 4 and Cycle 6 (each cycle is 21 days).
Maximum plasma concentration
Maximum plasma concentration (Cmax) is defined as maximum plasma concentration after dose.
Time frame: The Cmax of zanubrutinib is determined at 2h postdose on day 2 of Cycle 2 (each cycle is 21 days) and the Cmax of lenalidomide is determined at 1h postdose on day 2 of Cycle 2 (each cycle is 21 days).
Area under the plasma concentration-time curve
Area under the plasma concentration-time curve (AUC) is defined as the area under the curve from time zero to time of last quantifiable plasma concentration after dose.
Time frame: The AUC of zanubrutinib is determined at predose (0h), 2h and 24h postdose on day 2 of Cycle 2 (each cycle is 21 days) and the AUC of lenalidomide is determined at predose (0h), 1h and 24h postdose on day 2 of Cycle 2 (each cycle is 21 days).
Steady-state trough concentration
Steady-state trough concentration (Css,min) is defined as minimum plasma concentration after dose.
Time frame: The Css,min of zanubrutinib is determined at 24h postdose on day 2 of Cycle 2 (each cycle is 21 days) and the Css,min of lenalidomide is determined at 24h postdose on day 2 of Cycle 2 (each cycle is 21 days).