Clinical trial NCT04435743: Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin's Lymphomas
Official title: The Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin Lymphomas: a Real-world Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-hodgkin Lymphoma,B Cell
Keywords: lenalidomide
Non-hodgkin Lymphoma,B Cell
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: At the end of Cycle 6 (each cycle is 21-28 days)
Secondary outcomes:
measure: Complete response rate
timeFrame: At the end of Cycle 6 (each cycle is 21-28 days)
measure: Partial response rate
timeFrame: At the end of Cycle 6 (each cycle is 21-28 days)
measure: Duration of response
timeFrame: From response evaluation to study completion, an average of 2 years.
measure: 2-year progression-free survival
timeFrame: 2 years after entry onto study
measure: Overall survival
timeFrame: From entry onto study to study completion, an average of 2 years.
measure: Adverse event
timeFrame: From entry onto study to study completion, an average of 2 years.
measure: Severe adverse event
timeFrame: From entry onto study to study completion, an average of 2 years.
measure: Dosage adjustment
timeFrame: From entry onto study to study completion, an average of 2 years.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
Study officials:
References: