Intravascular Large B-Cell Lymphoma
Conditions
Keywords
Intravascular Large B-Cell Lymphoma, zanubrutinib, R-CHOP
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.
Interventions
DRUGZanubrutinib
160mg Bid, oral, d1-21 in a 21-day cycle for 8 cycles.
DRUGRituximab
Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
DRUGCyclophosphamide
Cyclophosphamide 750mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
DRUGEpirubicin
Epirubicin 70mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
DRUGVindesine
Vindesine 4mg intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol
DRUGPrednisone
Prednisone 60mg/m2 orally d1-5, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 years progression-free survival | 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 | 2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow up without relapsing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate(ORR) | 6 weeks after the end of 8 cycles of induction (each cycle is 21 days). | ORR was calculated by the proportion of patients who achieved complete remission and partial remission. |
Countries
China
Contacts
Primary ContactHui Xu
Outcome results
None listed