Status:
UNKNOWN
Phase II Study of Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Hospital
Beijing Tongren Hospital
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a prospective multicenter single-arm phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory prima...
Detailed Description
All the patients will be treated with Orelabrutinib combined with PD-1 inhibitor ：Orelabrutinib 150mg qd，Tislelizumab Injection 200mg d1 or Sintilimab injection 200mg d1， every 21-day for 1 cycle). Pa...
Eligibility Criteria
Inclusion
- Age ≥18 years old ≤75 Years old, male or female
- Primary Central nerves system lymphoma confirmed by cytology or histology according to WHO2016 criteria
- No evidence of systemic lymphoma
- Patients with a clear diagnosis of relapsed and/or refractory PCNSL: they received at least one regimen containing methotrexate.
- At least one measurable lesion according to Lugano 2014 criteria
- Adequate organ function and adequate bone marrow reserve
Exclusion
- Malignant tumors other than B-NHL 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
- Any systemic antitumor therapy performed within 2 weeks before enrollment
- Previous use of other BTK inhibitors or PD-1 inhibitors.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 24 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04899427
Start Date
March 24 2021
End Date
October 24 2023
Last Update
May 24 2021
Active Locations (1)
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1
Wei Zhang
Beijing, Beijing Municipality, China, 100730