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

NCT ID: NCT04899570

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-04-01

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

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 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.

Conditions

Intravascular Large B-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zanubrutinib combined with R-CHOP

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 The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens.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.

Group Type: EXPERIMENTAL

Zanubrutinib

Intervention Type: DRUG

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

Rituximab

Intervention Type: DRUG

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

Cyclophosphamide

Intervention Type: DRUG

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

Epirubicin

Intervention Type: DRUG

Epirubicin 70mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol

Vindesine

Intervention Type: DRUG

Vindesine 4mg intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol

Prednisone

Intervention Type: DRUG

Prednisone 60mg/m2 orally d1-5, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol

Interventions

Zanubrutinib

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

Intervention Type: DRUG

Rituximab

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

Intervention Type: DRUG

Cyclophosphamide

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

Intervention Type: DRUG

Epirubicin

Epirubicin 70mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol

Intervention Type: DRUG

Vindesine

Vindesine 4mg intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol

Intervention Type: DRUG

Prednisone

Prednisone 60mg/m2 orally d1-5, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol

Intervention Type: DRUG

Other Intervention Names

BRUKINSA; Rituxan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daobin Zhou

Role: STUDY_CHAIR

Department of Hematology, Peking University First Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Xu

Role: CONTACT

pumchkyc@126.com

+861069156874

Facility Contacts

Zhang Yan

Role: primary

zhangyan10659@pumch.cn

+86 13810000485

Other Identifiers

PUMCH-NHL-008

Identifier Type: -

Identifier Source: org_study_id