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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Lenalidomide is given as any following dosage: 1. 25mg, PO QD, Day 1-10 in every 21 days for 6 cycles; 2. 15mg, PO QD, Day 1-14 in every 21 days for 6 cycles; 3. 25mg, PO QD, Day 1-10 in every 21 days for 1 year; 4. 25mg, PO QD, Day 1-21 in every 28 days for 1 year; 5. 25mg, PO QD, Day 1-10 in every 28 days for 12 cycles; 6. 20mg, PO QD, Day 1-21 in every 28 days for 12 cycles.
Shanghai Ruijin Hospital
Shanghai, China
RECRUITINGObjective response rate
Rate of objective response, defined according to Lugano 2014 criterion.
Time frame: At the end of Cycle 6 (each cycle is 21-28 days)
Complete response rate
Rate of complete response, defined according to Lugano 2014 criterion
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 years after entry onto study
Overall survival
Death as a result of any cause, measured from entry onto study, in all patients
Time frame: 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
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Time frame: 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
Time frame: From entry onto study to study completion, an average of 2 years.
Dosage adjustment
Time frame: From entry onto study to study completion, an average of 2 years.