Clinical Research Directory

ZR2 Versus R2 Regimen in the Treatment of Newly Diagnosed Follicular Lymphoma

Primary Objective: To compare the complete response rate (CR rate) after induction treatment between the ZR2 regimen and the R2 regimen.\<br/\>\<br/\>Secondary Objectives: To compare the objective response rate (ORR) after induction treatment, progression-free survival (PFS), progression of disease within 24 months (POD24) rate, duration of response (DOR), overall survival (OS), treatment-related adverse events (AEs), and patient quality of life between the two groups.\<br/\>\<br/\>Exploratory Objectives: To compare the histological .transformation (HT) rate at disease progression, minimal residual disease (MRD) negativity rate, changes in tumor microenvironment (TME) biomarkers, and the relationship between genetic biomarkers and efficacy/prognosis between the two groups; to further reveal the unique pattern of systemic immune status remodeling by the ZR2 regimen and identify potential efficacy-predictive biomarkers. Study Nature Interventional study Study Design Prospective, randomized controlled, exploratory, multicenter clinical study Sample Size 100 cases Principal Investigator Professor Zhou Keshu Sponsor The Affiliated Cancer Hospital of Zhengzhou University Treatment Regimens (4 weeks per cycle) ZR2 Group\<br/\>- Induction Treatment (6 cycles): Zebutinib 160mg bid starting from C1D1; Rituximab 375mg/m² on Day 1; Lenalidomide 20mg qd on Days 1-21.\<br/\>- Maintenance Treatment: Rituximab 375mg/m² on Day 1 (once every 8 weeks for 2 years); Lenalidomide ;ZR2 Group\<br/\>- Induction Treatment (6 cycles): Zebutinib 160mg bid starting from C1D1; Rituximab 375mg/m² on Day 1; Lenalidomide 20mg qd on Days 1-21.\<br/\>- Maintenance Treatment: Rituximab 375mg/m² on Day 1 (once every 8 weeks for 2 years); Lenalidomide 10mg qd on Days 1-21 (once every 4 weeks for 12 times).\<br/\>\<br/\>R2 Group\<br/\>- Induction Treatment (6 cycles): Rituximab 375mg/m² on Day 1; Lenalidomide 20mg qd on Days 1-21.\<br/\>- Maintenance Treatment: Rituximab 375mg/m² on Day 1 (once every 8 weeks for 2 years); Lenalidomide 10mg qd on Days 1-21 (once every 4 weeks for 12 times).\<br/\>\<br/\>Note: Patients who achieve PR during the first 6 cycles of induction treatment may receive an additional 3 to 6 cycles of lenalidomide 20mg until CR is achieved; thereafter, during maintenance treatment, lenalidomide 10mg PO qd is administered on Days 1-21 (once every 4 weeks for 12 times). Study Endpoints:Primary Endpoint: CR rate after induction treatment (assessed by the 2014 Lugano Classification for Non-Hodgkin Lymphomas).\<br/\>\<br/\>Secondary Endpoints: ORR after induction treatment; PFS; POD24 rate; OS; DOR; treatment-related AEs; patient quality of life.\<br/\>\<br/\>Exploratory Endpoints: HT rate at disease progression; MRD negativity rate; changes in TME biomarkers; relationship between genetic biomarkers and efficacy/prognosis. Follow-up Schedule:All patients will be followed up for 2 years after completing treatment, once every 3 months.

Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas

The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.