Non-hodgkin Lymphoma,B Cell
Conditions
Keywords
lenalidomide, Non-hodgkin Lymphoma,B Cell
Brief summary
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
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.
Interventions
DRUGLenalidomide
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.
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | At the end of Cycle 6 (each cycle is 21-28 days) | Rate of objective response, defined according to Lugano 2014 criterion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial response rate | At the end of Cycle 6 (each cycle is 21-28 days) | Rate of partial response, defined according to Lugano 2014 criterion |
| Duration of response | From response evaluation to study completion, an average of 2 years. | Time to relapse or progression, measured from documentation of response, in CR or PR patients |
| 2-year progression-free survival | 2 years after entry onto study | 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 |
| Complete response rate | At the end of Cycle 6 (each cycle is 21-28 days) | Rate of complete response, defined according to Lugano 2014 criterion |
| Adverse event | From entry onto study to study completion, an average of 2 years. | 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 |
| Severe adverse event | From entry onto study to study completion, an average of 2 years. | 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 |
| Dosage adjustment | From entry onto study to study completion, an average of 2 years. | — |
| Overall survival | From entry onto study to study completion, an average of 2 years. | Death as a result of any cause, measured from entry onto study, in all patients |
Countries
China
Contacts
Primary ContactWeili Zhao, M.D. and Ph.D
Outcome results
None listed