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

Primary Purpose

Intravascular Large B-Cell Lymphoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Zanubrutinib

Rituximab

Cyclophosphamide

Epirubicin

Vindesine

Prednisone

About this trial

This is an interventional treatment trial for Intravascular Large B-Cell Lymphoma focused on measuring Intravascular Large B-Cell Lymphoma, zanubrutinib, R-CHOP

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zanubrutinib combined with R-CHOP

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 The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens.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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

overall response rate(ORR)

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

Full Information

NCT ID

NCT04899570

First Posted

May 19, 2021

Last Updated

May 19, 2021

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04899570

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

April 1, 2023 (Anticipated)

Study Completion Date

April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intravascular Large B-Cell Lymphoma

Keywords

Intravascular Large B-Cell Lymphoma, zanubrutinib, R-CHOP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Zanubrutinib combined with R-CHOP

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Zanubrutinib

Other Intervention Name(s)

BRUKINSA

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Rituxan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Epirubicin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vindesine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

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

Primary Outcome Measure Information:

Title

2 years progression-free survival

Description

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 Outcome Measure Information:

Title

overall response rate(ORR)

Description

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hui Xu

Phone

+861069156874

pumchkyc@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daobin Zhou

Organizational Affiliation

Department of Hematology, Peking University First Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhang Yan

Phone

+86 13810000485

zhangyan10659@pumch.cn

12. IPD Sharing Statement

Learn more about this trial

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

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