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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 2

Conditions: Intravascular Large B-Cell Lymphoma

Treatments: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Prednisone; Drug: Vindesine; Drug: Rituximab; Drug: Zanubrutinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04899570

PUMCH-NHL-008

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Zanubrutinib combined with R-CHOP

Experimental group

Description:

The experimental arm will be treated zanubrutinib combined with R-CHOP regimen for 8 cycles. The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens. After 8 cycles of ZR-CHOP, the patients will be followed for 2 years to evaluate the PFS.

Treatment:

Drug: Zanubrutinib

Drug: Epirubicin

Drug: Cyclophosphamide

Drug: Rituximab

Drug: Prednisone

Drug: Vindesine