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

NCT06015464 | Unknown

• 1 other identifier: 2023-SR-190
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• CR rate of EOT

  CR rate at the end of treatment

  at the end of Cycle 6-8 (each cycle is 28 days)

Study Arms (2)

prospective cohort

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

Prospective cohort

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

Interventions

Orelabrutinib DRUG

Addition of novel BTK inhibitor, Orelabrutinib，150 mg qd, to standard treatment regimens, which include R-CHOP and Pola-R-CHP

Prospective cohort; prospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Untreated Diffuse large B-cell lymphoma (DLBCL) patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Hematological Department, People's Hospital of Jiangsu Province

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Lymphoma

Interventions

orelabrutinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: September 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: July 30, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)