Diffuse Large B Cell Lymphoma Clinical Trial
Official title:
A Single Arm, Multi-center, Phase II Clinical Trial of Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma and CD79A/CD79B Genetic Abnormality
This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of zanubrutinib combined with standard chemotherapy in the treatment for patients with diffuse large B cell lymphoma and CD79A/CD79B genetic abnormality.
Status | Recruiting |
Enrollment | 59 |
Est. completion date | December 25, 2025 |
Est. primary completion date | December 25, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Age between 18 to 70 years old (including 18 and 70) 2. Diagnosed as diffuse large B cell lymphoma 3. CD79A/CD79B genetic abnormality 4. Subjects must be untreated or R/R and either a or b (a: medium to high risk/high risk: International Prognostic Index (IPI) score 3-5, aaIPI score 2-3 or NCCN-IPI score= 4/ b: Immunohistochemical staining of double expression (BCL2 = 70% and C-MYC = 40%) or P53 protein mutation positive = 50%) 5. Having at least one measurable lesions 6. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1 7. Life expectancy no less than 3 months 8. enough main organ function 9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 10. Agreeing to sign the written informed consents Exclusion Criteria: 1. Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike 2. Diagnosed as grey-zone lymphoma 3. Diagnosed as primary mediastinal large B-cell lymphoma 4. Diagnosed as CD20 negative diffuse large B-cell lymphoma 5. Active malignant tumor need be treated at the same time 6. Other malignant tumor history 7. Serious surgery and trauma less than two weeks 8. Systemic therapy for serious acute/chronic infection 9. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 10. Vaccination with live attenuated vaccine less than 4 weeks 11. HIV-positive, AIDS patients and untreated active hepatitis 12. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months 13. Patients with a history of mental illness 14. Researchers determine unsuited to participate in this trial |
Country | Name | City | State |
---|---|---|---|
China | Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of complete remission for 3-4 weeks after induction treatment | the total proportion of patients with complete remission (CR) for 3-4 weeks after induction treatment | from the date of the first cycle of treatment to 3-4 weeks after induction treatment of the last included patient (each cycle is 21 days) | |
Secondary | objective response rate | the total proportion of patients with complete response (CR) and partial response (PR) | every 6 weeks from the day of the first cycle of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment (each cycle is 21 days) | |
Secondary | 2-year progression-free survival | the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first | from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 21 days) | |
Secondary | 2-year overall survival | from date of first day of treatment to the date of death by any cause | from date of the first cycle of treatment to the date of death from any cause, assessed up to 2 years (each cycle is 21 days) | |
Secondary | incidence and relationship with study drugs of grade 3-4 adverse events | the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03) | from the date of the first cycle of treatment to 18 months after last patient's enrollment (each cycle is 21 days) |
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