Status:
COMPLETED
Translational Study of Molecular Classification of Relapsed/Refractory Diffuse Large B-cell Lymphoma
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Wuxi People's Hospital
Shanghai Minhang Central Hospital
Conditions:
Lymphoma, Large B-Cell, Diffuse
Gene Expression Profiling
Eligibility:
All Genders
18+ years
Brief 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 lenalidomi...
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 inc...
Eligibility Criteria
Inclusion
- 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.
- a) 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT05318391
Start Date
April 14 2021
End Date
March 30 2022
Last Update
April 8 2022
Active Locations (1)
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1
Yian Zhang
Shanghai, Shanghai Municipality, China, 200032