Status:
UNKNOWN
ZR-CHOP in DLBCL With Specific Gene Abnormality
Lead Sponsor:
Fudan University
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ab...
Detailed Description
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 ab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 4 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05290337
Start Date
January 4 2022
End Date
January 4 2026
Last Update
March 22 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032