Trials / Unknown
UnknownNCT06015464
An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 81 (estimated)
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Orelabrutinib | Addition of novel BTK inhibitor, Orelabrutinib，150 mg qd, to standard treatment regimens, which include R-CHOP and Pola-R-CHP |
Timeline
- Start date
- 2023-09-01
- Primary completion
- 2024-12-30
- Completion
- 2025-07-30
- First posted
- 2023-08-29
- Last updated
- 2023-08-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06015464. Inclusion in this directory is not an endorsement.