Diffuse Large B-cell LymphomaNCT05690191
Chidamide in Patients With Recurrent and Refractory Diffuse Large b
An observational study of Diffuse Large B-cell Lymphoma, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Chidamide, Lenalidomide and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 169 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Aug 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diffuse Large B-cell Lymphoma
Who may be able to join
- The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
- Age 18 and above, no gender limitation;
- Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
- Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion > 1cm;
- The serum pregnancy test of female subjects of childbearing age was negative;
- Understand the test procedure and content, and sign the informed consent voluntarily.
Who cannot join
- The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
- Age 18 and above, no gender limitation;
- Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
- Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion > 1cm;
- The serum pregnancy test of female subjects of childbearing age was negative;
- Understand the test procedure and content, and sign the informed consent voluntarily.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Read the detailed description
This is a prospective, multicenter, observational investigator-initiated clinical study. The subjects were adults (18 years of age and older) diagnosed with relapsed/refractory diffuse large B-cell lymphoma who will begin cR2 therapy at the time of enrollment. Patients were required to complete a visit every 4 weeks, lasting 24 weeks from the first dosing of the study protocol. The first visit was considered an enrollment visit. The specific dosage of cR2 will be determined according to the standard clinical practice of the treating physician. Participation in the study did not affect treatment decisions. Patients who could not continue with the cR2 regimen would terminate the visit early and then withdraw from the study. According to the data collected from the experiment, the safety and effectiveness of the research scheme were analyzed.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Chidamide, Lenalidomide, Rituximab
- 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.
ChidamideDrug
Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses
LenalidomideDrug
Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle
RituximabDrug
Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Chidamide in combination with rituximab and lenalidomide | Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses); Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle; Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle Receives: Drug: Chidamide; Drug: Lenalidomide; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rates assessed by the investigator
Measured: 30 months
Secondary outcomes (1)
Adverse Events
Incidence of adverse events
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Jun 2021
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 169 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bingzong LI, Principal investigator, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690191
- Sponsor's protocol ID
- JD-LK-2021-095-02
- Status last verified
- Jan 2023
- First submitted
- 5 Dec 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05690191
- Acronym / sponsor ID
- JD-LK-2021-095-02
- Conditions
- Diffuse Large B-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 19 Jan 2023 (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.
A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Detailed description
This is a prospective, multicenter, observational investigator-initiated clinical study. The subjects were adults (18 years of age and older) diagnosed with relapsed/refractory diffuse large B-cell lymphoma who will begin cR2 therapy at the time of enrollment. Patients were required to complete a visit every 4 weeks, lasting 24 weeks from the first dosing of the study protocol. The first visit was considered an enrollment visit. The specific dosage of cR2 will be determined according to the standard clinical practice of the treating physician. Participation in the study did not affect treatment decisions. Patients who could not continue with the cR2 regimen would terminate the visit early and then withdraw from the study. According to the data collected from the experiment, the safety and effectiveness of the research scheme were analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide in combination with rituximab and lenalidomide | – | Drug: Chidamide, Drug: Lenalidomide, Drug: RituximabChidamide tablets: 20mg orally, twice a week (at least 3 days between doses); Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle; Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diffuse Large B-cell Lymphoma
Key inclusion criteria (6 listed)
- The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
- Age 18 and above, no gender limitation;
- Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
- Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion > 1cm;
- The serum pregnancy test of female subjects of childbearing age was negative;
Key exclusion criteria (6 listed)
- The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
- Age 18 and above, no gender limitation;
- Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
- Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion > 1cm;
- The serum pregnancy test of female subjects of childbearing age was negative;
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 |
|---|---|---|
| ChidamideChidamide tablets: 20mg orally, twice a week (at least 3 days between doses | Drug | Chidamide in combination with rituximab and lenalidomide |
| LenalidomideLenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle | Drug | Chidamide in combination with rituximab and lenalidomide |
| RituximabRituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle | Drug | Chidamide in combination with rituximab and lenalidomide |
Primary outcome
Objective response rate
Time frame: 30 months
Objective response rates assessed by the investigator
1 secondary outcome
Adverse Events
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
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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.
Bingzong LI principal investigator
Second Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-cell Lymphoma, run by Second Affiliated Hospital of Soochow University 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 6 inclusion and 6 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 19 Jan 2023. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 30 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 19 Jan 2023.