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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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The First Affiliated Hospital of Nanchang University

Intervention / Treatment
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* Drug: Orelabrutinib+R-CHOP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orelabrutinib+R-CHOP<br> | Drug: Orelabrutinib+R-CHOP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | 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 | 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 | 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 | Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0. | up to 30 months |