Diffuse Large B Cell Lymphoma
Conditions
Keywords
Zanubrutinib, gene mutation, MYC translocation
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.
Interventions
DRUGzanubrutinib
BTK inhibitor
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18-75 years old; 2. 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; 3. Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center- 4. normal hematological, hepatic and renal function. 5. Life expectancy of more than 3 months; 6. Patients had at least one measurable target lesion; 7. LVEF ≥ 50% 8. signed informed consent forms
Exclusion criteria
1. hypersensitivity to immunoglobulin; 2. primary central nerves lymphoma 3. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix; 4. With contraindication of steroid including uncontrolled diabetes; 5. Serious uncontrolled diseases and intercurrent infection; 6. Pregnant or lactating women; 7. hepatitis B infection with HBV-DNA ≥ 104
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year progression free survival | assessed up to 36 months | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | assessed up to 36 months | complete remission and partial remission |
| 3-year event free survival | assessed up to 36 months | From date of enrollment until the date of an event, including progression, death from any cause, new treatment. |
| 3-year overall survival | assessed up to 36 months | From date of enrollment until the date of death from any cause |
Countries
China
Outcome results
None listed