Diffuse Large B Cell LymphomaPhase 2R2DLBCL80NCT04622579
Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years
A Phase 2 study testing lenalidomide combined with rituximab in people with Diffuse Large B Cell Lymphoma and Age Over 80 Years, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Age Over 80 Years
- What is being tested?
- lenalidomide combined with rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2020to 31 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- thrombosis ;
- GFR<30 mL/min;
- other conditions not suitable for rituximab or lenalidomide application.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong provincial people's hospital
Guangzhou, Guangdong, 510080
Xinmiao Jiang, +86 20 81884713-80631, 296260860@qq.com
About this study
Official title: 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.
- Conditions
- Diffuse Large B Cell Lymphoma, Age Over 80 Years
- Being tested
- lenalidomide combined with rituximab
- Keywords
- lenalidomide
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomide combined with rituximabDrug
lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.
| Study group | Role | What they receive |
|---|---|---|
| lenalidomide combined with rituximab | Experimental | 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. Receives: Drug: lenalidomide combined with rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Overall response rate
Measured: 24 months
Secondary outcomes (3)
CR
Complete response
Measured: 24 months
OS
Overall survival
Measured: from date of treatment until the date of death from any cause, assessed up to 5 years
PFS
Progression-free survival
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start23 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou First People's Hospital, First People's Hospital of Foshan, Huizhou Municipal Central Hospital, Shantou Central Hospital
- Responsible party
- Principal investigator, Wenyu Li, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622579
- Sponsor's protocol ID
- 2020099H
- Acronym
- R2DLBCL80
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenalidomide Combined With Rituximab as Front-line Therapy in Elderly Patients Aged Over 80 Years With Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04622579
- Acronym / sponsor ID
- R2DLBCL80 / 2020099H
- Conditions
- Diffuse Large B Cell Lymphoma, Age Over 80 Years
- Keywords
- lenalidomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Guangzhou First People's Hospital, First People's Hospital of Foshan, Huizhou Municipal Central Hospital, Shantou Central Hospital
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lenalidomide combined with rituximab | Experimental | Drug: lenalidomide combined with rituximabRituximab 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. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age≧80 years ;
- ECOG score 0-2；
- untreated with pathologically confirmed CD20+ DLBCL ;
- expected life expectancy of ≥ 12 weeks;
- capable of swallowing tablets;
Key exclusion criteria (9 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenalidomide combined with rituximablenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained. | Drug | lenalidomide combined with rituximab |
Primary outcome
ORR
Time frame: 24 months
Overall response rate
3 secondary outcomes
CR
Time frame: 24 months
OS
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lenalidomide combined with rituximab in people with Diffuse Large B Cell Lymphoma and Age Over 80 Years, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinmiao Jiang (（+86）20-83827812, 296260860@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.