ZR-CHOP in DLBCL With Specific Gene Abnormality

Study Overview
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Brief Summary
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This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality.

Detailed Description
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This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.

Official Title
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Phase 2 Study of Zanubrutinib Plus RCHOP (ZR-CHOP) in Newly Diagnosed Diffuse Large B-cell Lymphoma With Specific Gene Abnormality

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: zanubrutinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old; histological confirmed, newly-diagnosed diffuse large B-cell lymphoma with one of the following gene abnormality including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation; Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center- normal hematological, hepatic and renal function. Life expectancy of more than 3 months; Patients had at least one measurable target lesion; LVEF ≥ 50% signed informed consent forms Exclusion Criteria: hypersensitivity to immunoglobulin; primary central nerves lymphoma History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix; With contraindication of steroid including uncontrolled diabetes; Serious uncontrolled diseases and intercurrent infection; Pregnant or lactating women; hepatitis B infection with HBV-DNA ≥ 104

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: ZR-CHOP<br> | Drug: zanubrutinib<br>* BTK inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year progression free survival | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first | assessed up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | complete remission and partial remission | assessed up to 36 months | 
| 3-year event free survival | From date of enrollment until the date of an event, including progression, death from any cause, new treatment. | assessed up to 36 months | 
| 3-year overall survival | From date of enrollment until the date of death from any cause | assessed up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zanubrutinib, gene mutation, MYC translocation