Lymphoma, Large B-Cell, DiffuseNCT05318391
Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma
An observational study of Lymphoma, Large B-Cell, Diffuse and Gene Expression Profiling, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of the study is to investigate the proportion of the cell-of-origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse, Gene Expression Profiling
- What is being tested?
- Gene expression profile
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2021to 30 Mar 2022
- 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: Relapsed/refractory DLBCL patients who had received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment.Patients with comprehensive history information and follow-up data and are able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.
Who may be able to join
- Histologically-confirmed diagnosis of DLBCL, including transformed large B-cell lymphoma from previous indolent lymphoma.
- Meet the definition of relapsed/refractory DLBCL.
- Patients received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment. The efficacy was evaluated by the investigators. Cohort plans to enroll one hundred patients with BTK inhibitors treatment (excluding the combination with lenalidomide), one hundred patients with lenalidomide treatment (excluding the combination with BTK inhibitors) and any number of the cases with BTK inhibitors and lenalidomide combination.
- BTK inhibitors include ibrutinib, zanubrutinib and acalabrutinib
- Patients with comprehensive history information and follow-up data.
- Patient able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.
Who cannot join
- The archived tumor tissue is too little to test.
- Patients with primary central nerve system large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
- R/R DLBCL patients receive BTK inhibitor or lenalidomide treatment for less than one cycle.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate the proportion of the cell-of-origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars.
Read the detailed description
This is a multi-center, observational, retrospective study that examines approximately 200 R/R DLBCL patients treated with BTK inhibitors or lenalidomide and its biosimilars. For patients meet the inclusion criteria, gene expression analysis is performed on formalin fixed paraffin-embedded tissue by using Canhelp-COO Assay, and determine the COO subtype for each specimen. The proportion of COO subtypes in R/R DLBCL and the correlation between COO subtypes and clinicopathological information are further analyzed.
- Being tested
- Gene expression profile
- Keywords
- Canhelp-COO Assay
- 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.
Gene expression profileDiagnostic test
Diagnostic Test:
The Canhelp-COO Assay (Canhelp Genomics CO., Ltd) for differentiating COO subtypes using gene expression analysis by real-time PCR (RT-PCR)
| Study group | Role | What they receive |
|---|---|---|
| Group/Cohort | Retrospective Cohort： Participants who diagnosed with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) patients and treated with BTK inhibitor or lenalidomide and its biosimilars. Receives: Diagnostic Test: Gene expression profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of the cell of origin subtypes in the study population
Investigate the proportion of the cell of origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars.
Measured: up to 24 weeks
Secondary outcomes (2)
correlation between COO subtypes and the ORR of the treatment of R/R DLBCL.
Based on the objective response rate (ORR) measured by the investigator, explore the correlation between COO subtypes and the efficacy of BTK inhibitors, lenalidomide and its biosimilars in the treatment of R/R DLBCL.
Measured: up to 24 weeks
correlation between COO subtypes and the PFS and OS of the treatment of R/R DLBCL.
Based on the progression-free survival (PFS) and overall survival (OS) measuredd by the investigator, explore the correlation between COO subtypes and the efficacy of BTK inhibitors, lenalidomide and its biosimilars in the treatment of R/R DLBCL .
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start14 Apr 2021
- Primary completion30 Jan 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Retrospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuxi People's Hospital, Shanghai Minhang Central Hospital
- Responsible party
- Principal investigator, Peng Liu, Shanghai Zhongshan Hospital
- Investigators
- Peng Liu, MD,PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318391
- Sponsor's protocol ID
- SHZS-DLBCL001
- Status last verified
- Mar 2022
- First submitted
- 8 May 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yan WH, Jiang XN, Wang WG, Sun YF, Wo YX, Luo ZZ, Xu QH, Zhou XY, Cao JN, Hong XN, Li XQ. Cell-of-Origin Subtyping of Diffuse Large B-Cell Lymphoma by Using a qPCR-based Gene Expression Assay on Formalin-Fixed Paraffin-Embedded Tissues. Front Oncol. 2020 Jun 5;10:803. doi: 10.3389/fonc.2020.00803. eCollection 2020.
PubMed 32582543
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05318391
- Acronym / sponsor ID
- SHZS-DLBCL001
- Keywords
- Canhelp-COO Assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Wuxi People's Hospital, Shanghai Minhang Central Hospital
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 8 Apr 2022 (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.
The purpose of the study is to investigate the proportion of the cell-of-origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars.
Detailed description
This is a multi-center, observational, retrospective study that examines approximately 200 R/R DLBCL patients treated with BTK inhibitors or lenalidomide and its biosimilars. For patients meet the inclusion criteria, gene expression analysis is performed on formalin fixed paraffin-embedded tissue by using Canhelp-COO Assay, and determine the COO subtype for each specimen. The proportion of COO subtypes in R/R DLBCL and the correlation between COO subtypes and clinicopathological information are further analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group/Cohort | – | Diagnostic Test: Gene expression profileRetrospective Cohort： Participants who diagnosed with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) patients and treated with BTK inhibitor or lenalidomide and its biosimilars. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Relapsed/refractory DLBCL patients who had received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment.Patients with comprehensive history information and follow-up data and are able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.
Key inclusion criteria (6 listed)
- Histologically-confirmed diagnosis of DLBCL, including transformed large B-cell lymphoma from previous indolent lymphoma.
- Meet the definition of relapsed/refractory DLBCL.
- Patients received BTK inhibitors and/or lenalidomide and its biosimilars after the failure of the first-line standard treatment. The efficacy was evaluated by the investigators. Cohort plans to enroll one hundred patients with BTK inhibitors treatment (excluding the combination with lenalidomide), one hundred patients with lenalidomide treatment (excluding the combination with BTK inhibitors) and any number of the cases with BTK inhibitors and lenalidomide combination.
- Patients with comprehensive history information and follow-up data.
- Patient able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.
Key exclusion criteria (3 listed)
- The archived tumor tissue is too little to test.
- Patients with primary central nerve system large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
- R/R DLBCL patients receive BTK inhibitor or lenalidomide treatment for less than one cycle.
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 |
|---|---|---|
| Gene expression profileDiagnostic Test: The Canhelp-COO Assay (Canhelp Genomics CO., Ltd) for differentiating COO subtypes using gene expression analysis by real-time PCR (RT-PCR) | Diagnostic test | Group/Cohort |
Primary outcome
proportion of the cell of origin subtypes in the study population
Time frame: up to 24 weeks
Investigate the proportion of the cell of origin (COO) subtypes in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) treated with BTK inhibitor or lenalidomide and its biosimilars.
2 secondary outcomes
correlation between COO subtypes and the ORR of the treatment of R/R DLBCL.
Time frame: up to 24 weeks
correlation between COO subtypes and the PFS and OS of the treatment of R/R DLBCL.
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Background: PubMed 32582543Yan WH, Jiang XN, Wang WG, Sun YF, Wo YX, Luo ZZ, Xu QH, Zhou XY, Cao JN, Hong XN, Li XQ. Cell-of-Origin Subtyping of Diffuse Large B-Cell Lymphoma by Using a qPCR-based Gene Expression Assay on Formalin-Fixed Paraffin-Embedded Tissues. Front Oncol. 2020 Jun 5;10:803. doi: 10.3389/fonc.2020.00803. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Peng Liu, MD,PhD principal investigator
Fudan 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 Lymphoma, Large B-Cell, Diffuse and Gene Expression Profiling, run by Shanghai Zhongshan 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 6 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: finished, as of the sponsor's last update on 8 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion of the cell of origin subtypes in the study population (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318391, which also lists 1 linked publication.
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 8 Apr 2022.