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

NCT ID: NCT04435743

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Non-hodgkin Lymphoma,B Cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DLBCL

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

Lenalidomide

Intervention Type 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.

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.

Lenalidomide

Intervention Type 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.

Maintenance

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

Lenalidomide

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhao Weili

First Deputy Director of Shanghai Institute of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Ruijin Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weili Zhao, M.D. and Ph.D

Role: CONTACT

+8613512112076

Facility Contacts

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Weili Zhao, M.D. and Ph.D

Role: primary

13512112076

Other Identifiers

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LEN-NHL

Identifier Type: -

Identifier Source: org_study_id

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