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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2025
  • participants needed
    20
  • sponsor
    Peking Union Medical College Hospital
Updated on 4 June 2021

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 d1prednison 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.

Details
Condition Intravascular Large B-Cell Lymphoma
Treatment Rituximab, cyclophosphamide, prednisone, Epirubicin, Vindesine, Zanubrutinib
Clinical Study IdentifierNCT04899570
SponsorPeking Union Medical College Hospital
Last Modified on4 June 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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