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

August 23, 2023 updated by: The First Affiliated Hospital with Nanjing Medical University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Hematological Department, People's Hospital of Jiangsu Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Untreated Diffuse large B-cell lymphoma (DLBCL) patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CR rate of EOT
Time Frame: at the end of Cycle 6-8 (each cycle is 28 days)
CR rate at the end of treatment
at the end of Cycle 6-8 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-SR-190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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