Status:
UNKNOWN
Zanubrutinib Combined With Tislelizumab in the Treatment of r/r PMBCL and EBV+ DLBCL
Lead Sponsor:
Ruijin Hospital
Conditions:
Primary Mediastinal Large B Cell Lymphoma
EBV-Positive DLBCL, Nos
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The study is to investigate the safety and efficacy of Zanubrutinib combined with Tislelizumab in the treatment of relapsed/refractory primary mediastinal large B-cell lymphoma and Epstein-Barr Virus-...
Detailed Description
R-CHOP regimen is the first-line therapy in DLBCL which greatly improved the efficacy of diffuse large B-cell lymphoma (DLBCL) and achieved good long-term survival. However, among DLBCL patients treat...
Eligibility Criteria
Inclusion
- Pathologically confirmed diffuse large B-cell lymphoma, EBV positive and primary mediastinal large B-cell lymphoma
- Have received at least one prior standard therapy line including Rituximab and anthracyclines.
- Age≥18
- ECOG 0,1,2
- Imaging accessible lesions
- Life expectancy\>3 months
- Informed consented
Exclusion
- Have received systemic or local treatment including chemotherapy within three weeks before enrollment
- Chronic or active infectious diseases that require systemic antibiotics, antifungals or antiviral therapy
- Lab at enrollment (Unless caused by lymphoma) : Neutrophile\<1.0\*10\^9/L , Hemoglobin\<80g/L, Platelet\<50\*10\^9/L, ALT or AST \>2\*ULN,AKP or bilirubin \>1.5\*ULN Creatinine\>1.5\*ULN
- Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons
- HIV infection
- If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA, DNA positive patients cannot be enrolled
- Previously received BTK inhibitor or anti-PD-1/PD-L1 treatment
- History of active autoimmune disease or severe autoimmune disease
- Need to be given corticosteroids (dose equivalent to prednisone \>20 mg/day) or other immunosuppressive agents within 14 days before the study drug administration
- A history of interstitial lung disease or non-infectious pneumonia, except for those caused by radiotherapy
- Need strong cytochrome P450 (CYP) 3A inhibitor or inducer drug treatment
- Received live vaccination within 28 days before the first dose of study drug
- Patients who can receive hematopoietic stem cell transplantation, and if the subject has received allogeneic stem cell transplantation within 6 months before the first administration of the study drug or has active graft-versus-host disease requiring continuous immunosuppressive therapy
- Have received any experimental drug within 28 days, or the toxicity of any previous chemotherapy has not been relieved to ≤ Grade 1
- History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, unless recovered for at least 2 years
- Have a history of other active malignancies within 2 years before entering the study, excluding cervical cancer in situ, local basal cell or squamous cell skin cancer that has been cured by adequate treatment; or the previous malignant tumor is localized and has undergone local radical treatment Treatment (surgery or other forms)
- Pregnant or nursing period
- Men or women who are fertile but refuse to take appropriate contraceptive measures, unless they have been surgically sterilized
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04705129
Start Date
January 1 2021
End Date
January 1 2024
Last Update
March 30 2021
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200020