Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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 lymphoma. Progression-free survival (PFS) of the cohort is the primary endpoint.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Cyclophosphamide; Epirubicin; Prednisone; Rituximab; Vindesine; Zanubrutinib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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