A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

August 13, 2023 updated by: Zengjun Li, Shandong Cancer Hospital and Institute

A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Dan Liu
  • Phone Number: 13256139207

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The First Ailliated Hospital of Nanchang University
        • Contact:
          • Fei Li
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
        • Contact:
          • Zengjun Li

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

Description

Inclusion Criteria:

  • Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma

    • Age 18-70 years
    • ECOG performance status 0-2
    • Ann Arbor stage II-IV
    • 8.Subjects who in line with the testing standard of the clinical trial laboratory
    • Life expectancy ≥ 3months

Exclusion Criteria:

  • • systemic lymphoma involved CNS.

    • Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases.
    • uncontrolled infections (including HBV, HCV, HIV/AIDS)
    • Subjects who prepared for transplantation
    • Pregnancy or active lactation

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: orelabrutinib+R-CHOP
Drug: Orelabrutinib+R-CHOP
Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete response rate
Time Frame: up to 24 weeks
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 24 weeks
ORR is defined as the proportion of patients with a best response of CR or PR
up to 24 weeks
2 years progression-free survival
Time Frame: From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
2 years overall survival
Time Frame: From date of receiving the first dose until the date of death from any cause,assessed up to 2 years
2 years overall survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive
From date of receiving the first dose until the date of death from any cause,assessed up to 2 years
The occurrence of adverse events and serious adverse events
Time Frame: up to 30 months
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
up to 30 months

Collaborators and Investigators

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

Sponsor

Shandong Cancer Hospital and Institute

Collaborators

The First Affiliated Hospital of Nanchang University

Investigators

  • Study Chair: zengjun Li, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

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 (Actual)

June 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDCHI-NHL-001

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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