Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin's Lymphomas

Non-hodgkin Lymphoma,B Cell Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04435743
• Other study ID #: LEN-NHL
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: December 2022

Study information

• Verified date: July 2020
• Source: Ruijin Hospital
• Contact: Weili Zhao, M.D. and Ph.D
• Phone: +8613512112076
• Email: zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-hodgkin Lymphoma,B Cell

Intervention

Drug:
• Lenalidomide
Lenalidomide is given as any following dosage: 25mg, PO QD, Day 1-10 in every 21 days for 6 cycles; 15mg, PO QD, Day 1-14 in every 21 days for 6 cycles; 25mg, PO QD, Day 1-10 in every 21 days for 1 year; 25mg, PO QD, Day 1-21 in every 28 days for 1 year; 25mg, PO QD, Day 1-10 in every 28 days for 12 cycles; 20mg, PO QD, Day 1-21 in every 28 days for 12 cycles.

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Partial response rate	Rate of partial response, defined according to Lugano 2014 criterion	At the end of Cycle 6 (each cycle is 21-28 days)
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Dosage adjustment		From entry onto study to study completion, an average of 2 years.