Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years
R2DLBCL80
1 other identifier
interventional
20
1 country
1
Brief Summary
About 40% of Diffuse large B cell lymphoma relapse or is refractory, age is a prognostic factor of DLBCL, as elderly patients are not capable to received standard treatment, the prognosis of elderly patients is poor especially those aged over 80 years. In this study,we aimed to investigate the safety and efficacy of the combination of lenalidomide and rituximab in elderly patients aged ≥ 80 years with untreated DLBCL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2020
CompletedFirst Submitted
Initial submission to the registry
November 5, 2020
CompletedFirst Posted
Study publicly available on registry
November 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedNovember 10, 2020
November 1, 2020
2.2 years
November 5, 2020
November 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ORR
Overall response rate
24 months
Secondary Outcomes (3)
CR
24 months
OS
from date of treatment until the date of death from any cause, assessed up to 5 years
PFS
from date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Study Arms (1)
lenalidomide combined with rituximab
EXPERIMENTALRituximab 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.
Interventions
lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.
Eligibility Criteria
You may qualify if:
- Age≧80 years ;
- ECOG score 0-2；
- untreated with pathologically confirmed CD20+ DLBCL ;
- expected life expectancy of ≥ 12 weeks;
- capable of swallowing tablets;
- GFR(by Cockcroft- Gault)≥30 ml/min;
- can sign written informed consent to participate in the study.
You may not qualify if:
- with CNS involvement;
- 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;
- with ≥ grade 2 peripheral neurophathy;
- with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks;
- received live vaccine within 28 days.;
- HIV-positive;
- thrombosis ;
- GFR\<30 mL/min;
- other conditions not suitable for rituximab or lenalidomide application.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guangdong Provincial People's Hospitallead
- Guangzhou First People's Hospitalcollaborator
- First People's Hospital of Foshancollaborator
- Huizhou Municipal Central Hospitalcollaborator
- Shantou Central Hospitalcollaborator
Study Sites (1)
Guangdong provincial people's hospital
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor of medicine
Study Record Dates
First Submitted
November 5, 2020
First Posted
November 10, 2020
Study Start
October 23, 2020
Primary Completion
December 31, 2022
Study Completion
March 31, 2023
Last Updated
November 10, 2020
Record last verified: 2020-11