Back to resultsA Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
Primary Purpose
The First Affiliated Hospital of Nanchang University
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Orelabrutinib+R-CHOP
Sponsored by
About this trial
This is an interventional treatment trial for The First Affiliated Hospital of Nanchang University
Eligibility Criteria
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
Sites / Locations
- The First Ailliated Hospital of Nanchang UniversityRecruiting
- Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
orelabrutinib+R-CHOP
Arm Description
Outcomes
Primary Outcome Measures
complete response rate
Secondary Outcome Measures
ORR
ORR is defined as the proportion of patients with a best response of CR or PR
2 years progression-free survival
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
2 years overall survival
2 years overall survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive
The occurrence of adverse events and serious adverse events
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Full Information
NCT ID
NCT05933967
First Posted
June 16, 2023
Last Updated
August 13, 2023
Sponsor
Shandong Cancer Hospital and Institute
Collaborators
The First Affiliated Hospital of Nanchang University
1. Study Identification
Unique Protocol Identification Number
NCT05933967
Brief Title
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Cancer Hospital and Institute
Collaborators
The First Affiliated Hospital of Nanchang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The First Affiliated Hospital of Nanchang University
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
orelabrutinib+R-CHOP
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Orelabrutinib+R-CHOP
Intervention Description
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.
Primary Outcome Measure Information:
Title
complete response rate
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
ORR
Description
ORR is defined as the proportion of patients with a best response of CR or PR
Time Frame
up to 24 weeks
Title
2 years progression-free survival
Description
2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing
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]
Title
2 years overall survival
Description
2 years overall survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive
Time Frame
From date of receiving the first dose until the date of death from any cause,assessed up to 2 years
Title
The occurrence of adverse events and serious adverse events
Description
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Time Frame
up to 30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zengjun Li
Phone
13642138692
Email
zengjunli@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Liu
Phone
13256139207
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zengjun Li
Organizational Affiliation
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
The First Ailliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Li
Facility Name
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zengjun Li
12. IPD Sharing Statement
Learn more about this trial
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
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