NCT04435743

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

The Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin Lymphomas: a Real-world Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-hodgkin Lymphoma,B Cell

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-06-17
• Last updated: 2020-07-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study