An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL

Study Overview
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Brief Summary
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To retrospectively collect information on DLBCL patients treated with orelabrutinib in combination with standard first-line regimens, pooled analysis of the association between recent efficacy and patient characteristics (including biomarkers) in different types of patients to assess the predictive value of ctDNA for prognosis and subsequent therapeutic adjustments during treatment; Prospective observation to collect information on the efficacy of orelabrutinib in combination with standard treatment regimens in specific types of populations (with a focus on genotyped patients such as MCD, BN2 and N1 subtypes) to validate the predictive value of ctDNA in diagnosis and treatment. Standard treatment regimens include the R-CHOP regimen and the Pola-R-CHOP regimen.

Official Title
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An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL

Conditions
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Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type

Intervention / Treatment
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* Drug: Orelabrutinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Diffuse large B-cell lymphoma (DLBCL) diagnosed by histopathology of the tumour, without any previous anti-tumour therapy or after ≤2 cycles of R-CHOP(like) or Pola-R-CHP therapy only Have a clear efficacy evaluation Patients eligible for Non-GCB or extra-nodal or dual expression or who, in the judgement of the investigator, would benefit from treatment with Orelabrutinib following genetic testing. Patients treated with at least 2 cycles of orelabrutinib in combination with an R-CHOP(like) or Pola-R-CHP regimen Exclusion Criteria: Lymphoma involving the central nervous system or soft meningeal metastases Transforming lymphoma, i.e. from other types of lymphoma such as follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukaemia or small B-cell lymphoma Primary mediastinal large B-cell lymphoma Patients with poorly controlled cardiovascular disease, infectious disease, etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prospective cohort<br>To retrospectively collect information on DLBCL patients treated with orelabrutinib in combination with standard first-line regimens, pooled analysis of the association between recent efficacy and patient characteristics (including biomarkers) in different types of patients to assess the predictive value of ctDNA for prognosis and subsequent therapeutic adjustments during treatment | Drug: Orelabrutinib<br>* Addition of novel BTK inhibitor, Orelabrutinib，150 mg qd, to standard treatment regimens, which include R-CHOP and Pola-R-CHP<br>|
| Prospective cohort<br>Prospective observation to collect information on the efficacy of orelabrutinib in combination with standard treatment regimens in specific types of populations (with a focus on genotyped patients such as MCD, BN2 and N1 subtypes) to validate the predictive value of ctDNA in diagnosis and treatment | Drug: Orelabrutinib<br>* Addition of novel BTK inhibitor, Orelabrutinib，150 mg qd, to standard treatment regimens, which include R-CHOP and Pola-R-CHP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR rate of EOT | CR rate at the end of treatment | at the end of Cycle 6-8 (each cycle is 28 days) |