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Trial Title:
A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
NCT ID:
NCT05933967
Condition:
The First Affiliated Hospital of Nanchang University
Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib+R-CHOP
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.
Arm group label:
orelabrutinib+R-CHOP
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Ailliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Li
Facility:
Name:
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
zengjun Li
Start date:
June 1, 2023
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Nanchang University
Agency class:
Other
Source:
Shandong Cancer Hospital and Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05933967
