Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT ID: NCT05318391
Last Updated: 2022-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
324 participants
OBSERVATIONAL
2021-04-14
2022-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
Gene expression profile
Diagnostic Test:
The Canhelp-COO Assay (Canhelp Genomics CO., Ltd) for differentiating COO subtypes using gene expression analysis by real-time PCR (RT-PCR)
Interventions
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Gene expression profile
Diagnostic Test:
The Canhelp-COO Assay (Canhelp Genomics CO., Ltd) for differentiating COO subtypes using gene expression analysis by real-time PCR (RT-PCR)
Eligibility Criteria
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Inclusion Criteria
2. Meet the definition of relapsed/refractory DLBCL.
3. 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.
a) BTK inhibitors include ibrutinib, zanubrutinib and acalabrutinib
4. Patients with comprehensive history information and follow-up data.
5. Patient able to provide written informed consent, agreeing that the donated samples and related information can be used for all medical research.
Exclusion Criteria
2. Patients with primary central nerve system large B-cell lymphoma or primary mediastinal large B-cell lymphoma.
3. R/R DLBCL patients receive BTK inhibitor or lenalidomide treatment for less than one cycle.
18 Years
ALL
No
Sponsors
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Wuxi People's Hospital
OTHER
Shanghai Minhang Central Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Peng Liu
Chief of hematology department
Principal Investigators
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Peng Liu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Yian Zhang
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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SHZS-DLBCL001
Identifier Type: -
Identifier Source: org_study_id
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