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
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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UNKNOWN
1000 participants
OBSERVATIONAL
2019-11-01
2022-12-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant or lactating women
* Patients who were not considered suitable for the study by the researchers
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
First Deputy Director of Shanghai Institute of Hematology
Locations
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Shanghai Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LEN-NHL
Identifier Type: -
Identifier Source: org_study_id
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