Zanubrutinib Combined With Tislelizumab in the Treatment of r/r PMBCL and EBV+ DLBCL (NCT04705129) | Clinical Trial Compass
UnknownPhase 2
Zanubrutinib Combined With Tislelizumab in the Treatment of r/r PMBCL and EBV+ DLBCL
China40 participantsStarted 2021-01-01
Plain-language 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-positive diffuse large B-cell lymphoma.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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…
What they're measuring
1
complete response rate
Timeframe: 21 days after 6 cycles of treatment (each cycle is 21 days)