DLBCL - Diffuse Large B Cell LymphomaNCT06026488
Real-World Study of DLBCL With Different Genetic Subtypes
An observational study of DLBCL - Diffuse Large B Cell Lymphoma and Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
To collect and evaluate the data of real-world treatment regimen, efficacy, safety and survival information of DLBCL patients with different genetic suptypes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma, Lymphoma
- What is being tested?
- Other
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: DLBCL patients with genetic subtypes belonging to one of the seven subtypes by NGS: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others
Who may be able to join
- Histologically-confirmed diffuse large B-cell lymphoma (DLBCL)
- Genetic subtype belonging to at least one of the seven subtypes by using next generation sequencing: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others
- Fully comprehension and signature of the informed consent form (ICF) for participation
Who cannot join
- Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period
- Severe mental illness
- Patients deemed unsuitable for inclusion by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, MD, PhD, zhao.weili@yahoo.com
Pengpeng Xu, MD, PhD, pengpeng_xu@126.com
About this study
Official title: A Real-World Study of Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Different Genetic Subtypes
To collect and evaluate the data of real-world treatment regimen, efficacy, safety and survival information of DLBCL patients with different genetic suptypes
Read the detailed description
DLBCL is a highly common malignant tumor in Asia. The aim of the study is to observe and explore the clinical information on DLBCL patients with different genetic subtypes and to analyze the clinical characteristics and prognosis of different molecular subtypes of DLBCL. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors. The results can guide future precision therapy for DLBCL.
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma, Lymphoma
- Being tested
- Other
- Keywords
- lymphoma, DLBCL, Genetic Subtype, real world analysis
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherOther
real world treatment and survival of DLBCL patients in China
| Study group | Role | What they receive |
|---|---|---|
| All enrolled patients | All patient who signed the consent form for participation to the study Receives: Other: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first.
Measured: Baseline up to data cut-off (Up to approximately 9 years)
Secondary outcomes (5)
ORR
Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR)
Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
CRR
Complete Remission Rate (CRR) is defined as the proportion of patients with CR
Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
OS
Overall survival (OS) refers to the time from receiving the first dose to death from any cause
Measured: Baseline up to data cut-off (Up to approximately 9 years)
DOR
Duration Of Remission (DOR) refers to the time from the first CR or PR to the time of the first PD or death from any cause
Measured: Baseline up to data cut-off (Up to approximately 9 years)
TTR
Time to remission (TTR) refers to the time from recruitment to the time first CR or PR
Measured: Approximately up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026488
- Sponsor's protocol ID
- DLBCL-RWS-01
- Status last verified
- Dec 2024
- First submitted
- 17 Aug 2023
- Last updated
- 19 Dec 2024
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Different Genetic Subtypes
- ClinicalTrials.gov ID
- NCT06026488
- Acronym / sponsor ID
- DLBCL-RWS-01
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma, Lymphoma
- Keywords
- lymphoma, DLBCL, Genetic Subtype, real world analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Sep 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.
To collect and evaluate the data of real-world treatment regimen, efficacy, safety and survival information of DLBCL patients with different genetic suptypes
Detailed description
DLBCL is a highly common malignant tumor in Asia. The aim of the study is to observe and explore the clinical information on DLBCL patients with different genetic subtypes and to analyze the clinical characteristics and prognosis of different molecular subtypes of DLBCL. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors. The results can guide future precision therapy for DLBCL.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled patients | – | Other: OtherAll patient who signed the consent form for participation to the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- DLBCL patients with genetic subtypes belonging to one of the seven subtypes by NGS: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others
Key inclusion criteria (3 listed)
- Histologically-confirmed diffuse large B-cell lymphoma (DLBCL)
- Genetic subtype belonging to at least one of the seven subtypes by using next generation sequencing: MCD, BN2, N1, ST2, A53, EZB (MYC+, MYC-) and others
- Fully comprehension and signature of the informed consent form (ICF) for participation
Key exclusion criteria (3 listed)
- Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period
- Severe mental illness
- Patients deemed unsuitable for inclusion by the investigator
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 |
|---|---|---|
| Otherreal world treatment and survival of DLBCL patients in China | Other | All enrolled patients |
Primary outcome
PFS
Time frame: Baseline up to data cut-off (Up to approximately 9 years)
Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death from any cause, whichever occurs first.
5 secondary outcomes
ORR
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
CRR
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
OS
Time frame: Baseline up to data cut-off (Up to approximately 9 years)
DOR
Time frame: Baseline up to data cut-off (Up to approximately 9 years)
TTR
Time frame: Approximately up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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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.
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 DLBCL - Diffuse Large B Cell Lymphoma and Lymphoma, run by Ruijin 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Baseline up to data cut-off (Up to approximately 9 years)). 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 Dec 2024.