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

July 6, 2020 updated by: Zhao Weili, Ruijin Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: At the end of Cycle 6 (each cycle is 21-28 days)
Rate of objective response, defined according to Lugano 2014 criterion.
At the end of Cycle 6 (each cycle is 21-28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: At the end of Cycle 6 (each cycle is 21-28 days)
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
Time Frame: At the end of Cycle 6 (each cycle is 21-28 days)
Rate of partial response, defined according to Lugano 2014 criterion
At the end of Cycle 6 (each cycle is 21-28 days)
Duration of response
Time Frame: From response evaluation to study completion, an average of 2 years.
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
Time Frame: 2 years after entry onto study
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
Time Frame: From entry onto study to study completion, an average of 2 years.
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
Time Frame: From entry onto study to study completion, an average of 2 years.
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
Time Frame: From entry onto study to study completion, an average of 2 years.
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
Time Frame: From entry onto study to study completion, an average of 2 years.
From entry onto study to study completion, an average of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEN-NHL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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