Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years
NCT ID: NCT04622579
Last Updated: 2020-11-10
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
PHASE2
20 participants
INTERVENTIONAL
2020-10-23
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lenalidomide combined with rituximab
Rituximab 375 mg/m2 i.v d1 q28d； Lenalidomide 10mg Po. d1-21 q28d. After 6 cycles, patients obtained CR or PR will continue with Lenalidomide maintenance till the 24th month.
lenalidomide combined with rituximab
lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.
Interventions
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lenalidomide combined with rituximab
lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.
Eligibility Criteria
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Inclusion Criteria
2. ECOG score 0-2；
3. untreated with pathologically confirmed CD20+ DLBCL ;
4. expected life expectancy of ≥ 12 weeks;
5. capable of swallowing tablets;
6. GFR(by Cockcroft- Gault)≥30 ml/min;
7. can sign written informed consent to participate in the study.
Exclusion Criteria
2. with other malignancy (not including adequate-treated non-melanoma cutaneum carcinoma); patients with other cancer but disease-free for ≥5 years can enter this study;
3. with ≥ grade 2 peripheral neurophathy;
4. with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks;
5. received live vaccine within 28 days.;
6. HIV-positive;
7. thrombosis ;
8. GFR\<30 mL/min;
9. other conditions not suitable for rituximab or lenalidomide application.
80 Years
ALL
No
Sponsors
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Guangzhou First People's Hospital
OTHER
First People's Hospital of Foshan
OTHER
Huizhou Municipal Central Hospital
OTHER
Shantou Central Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Wenyu Li
professor of medicine
Locations
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Guangdong provincial people's hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Xinmiao Jiang
Role: primary
Other Identifiers
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2020099H
Identifier Type: -
Identifier Source: org_study_id