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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLBCL | Treatment-naive or relapsed/refractory CD20+ diffuse large B-cell lymphoma patients who receive induction therapy containing lenalidomide. |
| |
| FL/MCL/MZL | Treatment-naive or relapsed/refractory CD20+ follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma patients who receive induction therapy containing lenalidomide. |
| |
| Maintenance | B-cell non-Hodgkin lymphoma patients who achieve complete or partial remission after induction therapy and receive maintenance therapy containing lenalidomide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide is given as any following dosage:
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao, M.D. and Ph.D | Contact | +8613512112076 | zhao.weili@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ruijin Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
| 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. |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |