Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin's Lymphomas

Study Overview
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Brief Summary
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Describe the treatment of B-cell non-Hodgkin lymphoma patients who receive lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs), and evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.

Detailed Description
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This is a multi-center prospective, observational real-world study, targeting patients with B-cell non-Hodgkin's lymphomas. This study is designed to evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting. This study will mainly focus on the following three cohorts: Cohort 1: patients diagnosed with CD20-positive diffuse large B-cell lymphoma; Cohort 2: patients diagnosed with CD20-positive follicle lymphoma; Cohort 3: patients on maintenance treatment who have achieved complete remission or partial remission after induction therapy.

Official Title
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The Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin Lymphomas: a Real-world Study.

Conditions
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Non-hodgkin Lymphoma,B Cell

Intervention / Treatment
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* Drug: Lenalidomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as B-cell non-Hodgkin's lymphoma Voluntary participation in this study and the signing of an informed consent form The researchers assessed that the patient will benefit from the treatment of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) Exclusion Criteria: Contradictions to any drug in the treatment regimen Pregnant or lactating women Patients who were not considered suitable for the study by the researchers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DLBCL<br>Treatment-naive or relapsed/refractory CD20+ diffuse large B-cell lymphoma patients who receive induction therapy containing lenalidomide. | Drug: Lenalidomide<br>* Lenalidomide is given as any following dosage: 25mg, PO QD, Day 1-10 in every 21 days for 6 cycles; 15mg, PO QD, Day 1-14 in every 21 days for 6 cycles; 25mg, PO QD, Day 1-10 in every 21 days for 1 year; 25mg, PO QD, Day 1-21 in every 28 days for 1 year; 25mg, PO QD, Day 1-10 in every 28 days for 12 cycles; 20mg, PO QD, Day 1-21 in every 28 days for 12 cycles.<br>|
| FL/MCL/MZL<br>Treatment-naive or relapsed/refractory CD20+ follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma patients who receive induction therapy containing lenalidomide. | Drug: Lenalidomide<br>* Lenalidomide is given as any following dosage: 25mg, PO QD, Day 1-10 in every 21 days for 6 cycles; 15mg, PO QD, Day 1-14 in every 21 days for 6 cycles; 25mg, PO QD, Day 1-10 in every 21 days for 1 year; 25mg, PO QD, Day 1-21 in every 28 days for 1 year; 25mg, PO QD, Day 1-10 in every 28 days for 12 cycles; 20mg, PO QD, Day 1-21 in every 28 days for 12 cycles.<br>|
| Maintenance<br>B-cell non-Hodgkin lymphoma patients who achieve complete or partial remission after induction therapy and receive maintenance therapy containing lenalidomide. | Drug: Lenalidomide<br>* Lenalidomide is given as any following dosage: 25mg, PO QD, Day 1-10 in every 21 days for 6 cycles; 15mg, PO QD, Day 1-14 in every 21 days for 6 cycles; 25mg, PO QD, Day 1-10 in every 21 days for 1 year; 25mg, PO QD, Day 1-21 in every 28 days for 1 year; 25mg, PO QD, Day 1-10 in every 28 days for 12 cycles; 20mg, PO QD, Day 1-21 in every 28 days for 12 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Rate of objective response, defined according to Lugano 2014 criterion. | At the end of Cycle 6 (each cycle is 21-28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | Rate of complete response, defined according to Lugano 2014 criterion | At the end of Cycle 6 (each cycle is 21-28 days) | 
| Partial response rate | Rate of partial response, defined according to Lugano 2014 criterion | At the end of Cycle 6 (each cycle is 21-28 days) | 
| Duration of response | Time to relapse or progression, measured from documentation of response, in CR or PR patients | From response evaluation to study completion, an average of 2 years. | 
| 2-year progression-free survival | The rate of patients who are free of disease progression or death as a result of any cause, measured from entry onto study, in all patients | 2 years after entry onto study | 
| Overall survival | Death as a result of any cause, measured from entry onto study, in all patients | From entry onto study to study completion, an average of 2 years. | 
| Adverse event | any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure | From entry onto study to study completion, an average of 2 years. | 
| Severe adverse event | An adverse event when the patient outcome is death, life-threatening, required intervention to prevent permanent impairment or damage, hospitalization, disability or permanent damage, congenital anomaly or birth defect, or other important medical events | From entry onto study to study completion, an average of 2 years. | 
| Dosage adjustment |  | From entry onto study to study completion, an average of 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lenalidomide, Non-hodgkin Lymphoma,B Cell