- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04622579
Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years (R2DLBCL80)
November 5, 2020 updated by: Wenyu Li, Guangdong Provincial People's Hospital
Lenalidomide Combined With Rituximab as Front-line Therapy in Elderly Patients Aged Over 80 Years With Diffuse Large B Cell Lymphoma
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
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
- Name: Xinmiao Jiang
- Phone Number: (+86)20-83827812
- Email: 296260860@qq.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- Guangdong Provincial People's Hospital
-
Contact:
- Xinmiao Jiang
- Phone Number: +86 20 81884713-80631
- Email: 296260860@qq.com
-
-
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
80 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: 24 months
|
Overall response rate
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CR
Time Frame: 24 months
|
Complete response
|
24 months
|
OS
Time Frame: from date of treatment until the date of death from any cause, assessed up to 5 years
|
Overall survival
|
from date of treatment until the date of death from any cause, assessed up to 5 years
|
PFS
Time Frame: 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
|
Progression-free survival
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 23, 2020
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
March 31, 2023
Study Registration Dates
First Submitted
November 5, 2020
First Submitted That Met QC Criteria
November 5, 2020
First Posted (Actual)
November 10, 2020
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 5, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
- Rituximab
Other Study ID Numbers
- 2020099H
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
Clinical Trials on Diffuse Large B Cell Lymphoma
-
Memorial Sloan Kettering Cancer CenterRecruitingLymphoma | Lymphoma, B-Cell | DLBCL - Diffuse Large B Cell Lymphoma | Large B-cell Lymphoma | Large-cell Lymphoma | Mediastinal B-Cell Diffuse Large Cell LymphomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); AmgenActive, not recruitingRecurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | CD20 Positive | Stage I Diffuse Large B-Cell Lymphoma | Stage II Diffuse Large B-Cell Lymphoma | Stage III Diffuse Large B-Cell Lymphoma | Stage IV Diffuse Large B-Cell LymphomaUnited States
-
University Hospital Southampton NHS Foundation...Hoffmann-La RocheTerminatedDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited Kingdom
-
Qian WenbinNot yet recruitingDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaChina
-
National Cancer Institute (NCI)WithdrawnDiffuse, Large B-cell Lymphoma | Lymphoma, Diffuse Large-Cell | Lymphoma, Diffuse Large-Cell B-cell | Large-Cell Lymphoma, Diffuse
-
Dana-Farber Cancer InstituteBayer; AbbVieActive, not recruitingDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited States
-
Memorial Sloan Kettering Cancer CenterSanofi; Columbia University; Medical College of Wisconsin; University of Rochester and other collaboratorsActive, not recruitingDiffuse Large B-cell Lymphoma (DLBCL) | Relapsed Diffuse Large B-cell Lymphoma (DLBCL) | Refractory Diffuse Large B-cell Lymphoma (DLBCL)United States
-
Autolus LimitedCompletedDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | DLBCL | Relapsed Diffuse Large B-Cell LymphomaUnited States, United Kingdom
-
Herlev HospitalOdense University Hospital; Zealand University Hospital; Aarhus University Hospital and other collaboratorsCompletedDiffuse Large B-cell Lymphoma Recurrent | Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma Cell of Origin
-
UNC Lineberger Comprehensive Cancer CenterCephalonCompletedLymphoma | Diffuse Large B-Cell Lymphoma | Lymphoma, Diffuse Large-Cell | Diffuse Large-Cell LymphomaUnited States
Clinical Trials on lenalidomide combined with rituximab
-
Ruijin HospitalNot yet recruitingLymphoma, Large B-Cell, DiffuseChina
-
Cancer Institute and Hospital, Chinese Academy...Not yet recruitingRefractory Lymphoma | DLBCL | MYD88 Gene Mutation | Relapse | CD79A Gene Mutation | CD79B Gene Mutation
-
Ruijin HospitalThe First Affiliated Hospital of Nanchang University; Qilu Hospital of Shandong... and other collaboratorsRecruiting
-
The First Affiliated Hospital of Xiamen UniversityThe First Affiliated Hospital with Nanjing Medical University; Sun Yat-sen... and other collaboratorsRecruitingFollicular Lymphoma | DLBCL - Diffuse Large B Cell LymphomaChina
-
Swiss Group for Clinical Cancer ResearchTerminatedLymphomaSwitzerland, Norway, Sweden
-
Fudan UniversityCompleted
-
RenJi HospitalNot yet recruiting
-
MD Anderson International Spain SACelgene CorporationCompletedChronic Lymphocytic LeukemiaSpain
-
ART Fertility Clinics LLCCompleted
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalCompleted