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

Peking Union Medical College Hospital20 enrolled

Overview

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.

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 interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of ZR-CHOP. The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens. During the following-up, surveillance physical examination and CT scans should be performed every 6 months for 2 years to determine the status of disease.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intravascular Large B-Cell Lymphoma

Interventions

ZanubrutinibDRUG

160mg Bid, oral, d1-21 in a 21-day cycle for 8 cycles.

RituximabDRUG

Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol

CyclophosphamideDRUG

Cyclophosphamide 750mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

2 years progression-free survival

2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow up without relapsing.

Time frame: from the date of treatment to the subject finished his 2 years follow-up phase or the disease relapsed or the death due to lymphoma

Secondary Outcomes

overall response rate(ORR)

ORR was calculated by the proportion of patients who achieved complete remission and partial remission.

Time frame: 6 weeks after the end of 8 cycles of induction (each cycle is 21 days).

Central Contacts

Hui Xu

CONTACT

+861069156874 pumchkyc@126.com

Data from ClinicalTrials.gov

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