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

Not yet recruiting

• Conditions: Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type
• Interventions: Drug: Orelabrutinib

• Registration Number: NCT06015464
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-23
• Study First Posted: 2023-08-29
• Last Update Posted: 2023-08-29
• Study Start: 2023-09-01
• Primary Completion: 2024-12-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective cohort	Orelabrutinib	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
prospective cohort	Orelabrutinib	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

Primary Outcome Measures

Name	Time	Method
CR rate of EOT	at the end of Cycle 6-8 (each cycle is 28 days)	CR rate at the end of treatment

Trial Locations

Locations (1)

Hematological Department, People's Hospital of Jiangsu Province; 🇨🇳 Nanjing, Jiangsu, China