Status:
UNKNOWN
Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Intravascular Large B-Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a prospective single-arm phase II study, and the purpose of this study is to evaluate the efficiency of zanubrutinib combined with R-CHOP regimen in newly diagnosed primary intraocular lymphom...
Detailed Description
All the eligible patients will be treated with ZR-CHOP regimen (Rituximab 375mg/m2 IV d1, cyclophosphamide 750mg/m2 IV d1, epirubicin 70mg/m2 IV d1, vindesine 4mg IV d1，prednison 60mg/m2 d1-5 PO). An ...
Eligibility Criteria
Inclusion
- The patient volunteered to participate in the study and signed the Informed Consent
- Age ≥18 years old ≤70 Years old, male or female
- Expected survival ≥ 12 weeks
- Intravascular large B-cell lymphoma confirmed by cytology or histology according to WHO2016 criteria
- Never received any anti-tumor therapies.
- Adequate organ function and adequate bone marrow reserve
Exclusion
- Malignant tumors other than IVLBCL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
- Active HIV, HBV, HCV or treponema pallidum infection
- Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
- Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04899570
Start Date
April 1 2021
End Date
April 1 2025
Last Update
May 24 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730