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Trial Title:
An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL
NCT ID:
NCT06015464
Condition:
Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type
Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib
Description:
Addition of novel BTK inhibitor, Orelabrutinib，150 mg qd, to standard treatment regimens,
which include R-CHOP and Pola-R-CHP
Arm group label:
Prospective cohort
Arm group label:
prospective cohort
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.
Criteria for eligibility:
Study pop:
Untreated Diffuse large B-cell lymphoma (DLBCL) patients
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hematological Department, People's Hospital of Jiangsu Province
Address:
City:
Nanjing
Zip:
210029
Country:
China
Start date:
September 1, 2023
Completion date:
July 30, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06015464
