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

Intravascular Large B-Cell Lymphoma Clinical Trial

Official title:

A Prospective Phase II Study of Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899570
• Other study ID #: PUMCH-NHL-008
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2021
• Source: Peking Union Medical College Hospital
• Contact: Hui Xu
• Phone: +861069156874
• Email: pumchkyc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Intravascular Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Zanubrutinib
160mg Bid, oral, d1-21 in a 21-day cycle for 8 cycles.
• Rituximab
Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
• Cyclophosphamide
Cyclophosphamide 750mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
• Epirubicin
Epirubicin 70mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
• Vindesine
Vindesine 4mg intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol
• Prednisone
Prednisone 60mg/m2 orally d1-5, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	overall response rate(ORR)	ORR was calculated by the proportion of patients who achieved complete remission and partial remission.	6 weeks after the end of 8 cycles of induction (each cycle is 21 days).