A Phase 2 interventional study of Zanubrutinib and Rituximab in Intravascular Large B-Cell Lymphoma, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-24.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
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.
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.
Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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 The interim evaluation will be performed after 4 cycles, and the patients who can't achieve PR or CR will be withdrawn from this trial and receive salvage regimens.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.
Drug: Zanubrutinib · Drug: Rituximab · Drug: Cyclophosphamide · Drug: Epirubicin · Drug: Vindesine · Drug: Prednisone
160mg Bid, oral, d1-21 in a 21-day cycle for 8 cycles.
Also known as: BRUKINSA
Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
Also known as: Rituxan
Cyclophosphamide 750mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
Epirubicin 70mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
Vindesine 4mg intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol
Prednisone 60mg/m2 orally d1-5, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol
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.
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
overall response rate(ORR)
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).
Started Apr 2021 (actual). Primary completion is estimated for Apr 2023, 24 months after the start.
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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zanubrutinib
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