An observational study in Non-hodgkin Lymphoma,B Cell, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Ruijin Hospital · Observational
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study focus on patients diagnosed with B-cell non-Hodgkin's lymphoma and treated with lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.
Exclusion Criteria:
Treatment-naive or relapsed/refractory CD20+ diffuse large B-cell lymphoma patients who receive induction therapy containing lenalidomide.
Drug: Lenalidomide
Treatment-naive or relapsed/refractory CD20+ follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma patients who receive induction therapy containing lenalidomide.
Drug: Lenalidomide
B-cell non-Hodgkin lymphoma patients who achieve complete or partial remission after induction therapy and receive maintenance therapy containing lenalidomide.
Drug: Lenalidomide
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.
Objective 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
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.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ruijin Hospital