Status:
SUSPENDED
Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Diffuse Large B Cell Lymphoma
CD79A Gene Mutation
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 diffus...
Detailed Description
Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma (NHL). Currently, R-CHOP is world-widely used in the first-line treatment for DLBCL. There are about one second ...
Eligibility Criteria
Inclusion
- Age between 18 to 75 years old (including 18 and 75)
- Diagnosed as diffuse large B cell lymphoma
- CD79A/CD79B genetic abnormality
- Subjects with untreated or relapsed/refractory DLBCL
- Having at least one measurable lesions
- World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-1
- Life expectancy no less than 3 months
- enough main organ function
- 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
- Agreeing to sign the written informed consents
Exclusion
- Diagnosed as high-grade B-cell lymphoma, including non-specified and double-strike or triple-strike
- Diagnosed as grey-zone lymphoma
- Diagnosed as primary mediastinal large B-cell lymphoma
- Diagnosed as CD20 negative diffuse large B-cell lymphoma
- Active malignant tumor need be treated at the same time
- Other malignant tumor history
- Serious surgery and trauma less than two weeks
- Systemic therapy for serious acute/chronic infection
- Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
- Vaccination with live attenuated vaccine less than 4 weeks
- HIV-positive, AIDS patients and untreated active hepatitis
- Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
- Patients with a history of mental illness
- Researchers determine unsuited to participate in this trial
Key Trial Info
Start Date :
December 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2025
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04668365
Start Date
December 25 2020
End Date
December 25 2025
Last Update
April 25 2025
Active Locations (1)
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1
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China