Back to resultsZR-CHOP in DLBCL With Specific Gene Abnormality
Primary Purpose
Diffuse Large B Cell Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
zanubrutinib
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring Zanubrutinib, gene mutation, MYC translocation
Eligibility Criteria
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
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ZR-CHOP
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Objective response rate
complete remission and partial remission
3-year event free survival
From date of enrollment until the date of an event, including progression, death from any cause, new treatment.
3-year overall survival
From date of enrollment until the date of death from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05290337
Brief Title
ZR-CHOP in DLBCL With Specific Gene Abnormality
Official Title
Phase 2 Study of Zanubrutinib Plus RCHOP (ZR-CHOP) in Newly Diagnosed Diffuse Large B-cell Lymphoma With Specific Gene Abnormality
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
January 4, 2024 (Anticipated)
Study Completion Date
January 4, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 abnormality.
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 abnormality, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
Zanubrutinib, gene mutation, MYC translocation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ZR-CHOP
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
zanubrutinib
Intervention Description
BTK inhibitor
Primary Outcome Measure Information:
Title
3-year progression free survival
Description
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Time Frame
assessed up to 36 months
Secondary Outcome Measure Information:
Title
Objective response rate
Description
complete remission and partial remission
Time Frame
assessed up to 36 months
Title
3-year event free survival
Description
From date of enrollment until the date of an event, including progression, death from any cause, new treatment.
Time Frame
assessed up to 36 months
Title
3-year overall survival
Description
From date of enrollment until the date of death from any cause
Time Frame
assessed up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qunling Zhang, doctor
Phone
64175590
Ext
88900
Email
zqldoc@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ZR-CHOP in DLBCL With Specific Gene Abnormality
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