Orelabrutinib+R-CHOP
DrugOrelabrutinib 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.
Recruiting
NCT Number: NCT05933967
A Study 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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
The First Ailliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Loading trial locations.
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
complete response rate
Time frame: up to 24 weeks
Secondary outcomes
-
ORR
Time frame: up to 24 weeks
ORR is defined as the proportion of patients with a best response of CR or PR
-
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
-
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
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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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shandong Cancer Hospital and Institute
Other
Collaborators
- The First Affiliated Hospital of Nanchang University
Registry information
Official study 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
Important dates
- Study start
- 2023
- Primary completion
- 2024
- Study completion
- 2026
- First posted
- Jul 6, 2023
- Registry last updated
- Aug 15, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.