Clinical trial · Observational
An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orelabrutinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- prospective cohort
- description
- 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
- interventionNames
- Drug: Orelabrutinib
- label
- Prospective cohort
- description
- 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
- interventionNames
- Drug: Orelabrutinib
Primary outcomes (1)
- measure
- CR rate of EOT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available