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

NCT04435743 | Unknown DMC FDA Drug

• 1 other identifier: LEN-NHL
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-hodgkin Lymphoma,B Cell

Keywords

lenalidomide; Non-hodgkin Lymphoma,B Cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Complete response rate

  At the end of Cycle 6 (each cycle is 21-28 days)

• Partial response rate

  At the end of Cycle 6 (each cycle is 21-28 days)

• Duration of response

  From response evaluation to study completion, an average of 2 years.

• 2-year progression-free survival

  2 years after entry onto study

• Overall survival

  From entry onto study to study completion, an average of 2 years.

Study Arms (3)

DLBCL

Treatment-naive or relapsed/refractory CD20+ diffuse large B-cell lymphoma patients who receive induction therapy containing lenalidomide.

Drug: 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.

Drug: Lenalidomide

Maintenance

B-cell non-Hodgkin lymphoma patients who achieve complete or partial remission after induction therapy and receive maintenance therapy containing lenalidomide.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

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.

DLBCL; FL/MCL/MZL; Maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Contradictions to any drug in the treatment regimen
• Pregnant or lactating women
• Patients who were not considered suitable for the study by the researchers

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Weili Zhao, M.D. and Ph.D

CONTACT

+8613512112076; zhao.weili@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director of Shanghai Institute of Hematology

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 17, 2020
• Study Start: November 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

CN (1)