A Phase 2 interventional study of Zanubrutinib and Tislelizumab in Primary Mediastinal Large B Cell Lymphoma and EBV-Positive DLBCL, Nos, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
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.
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 treated with R-CHOP, EBV+ had a lower 5-year OS than EBV- patients (65% vs 82%). For primary mediastinal large B-cell lymphoma (PMBCL), although the initial treatment has a better prognosis than DLBCL, there are still 10% to 30% of PMBCL patients with primary refractory or relapsed disease, and the prognosis is poor.
Zanubrutinib combined with Tislelizumab has been proved efficient in relapsed or refractory NHLs, with ORR rate 37%, CR rate of 16.7%. This phase II, prospective, open-label, single-arm study will evaluate the efficacy and safety 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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
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Exclusion Criteria:
Zanubrutinib 160mg Bid, D1-21, po;Tislelizumab 200mg, D1, ivgtt
Drug: Zanubrutinib · Drug: Tislelizumab
160mg Bid, D1-21, po
200mg, D1, ivgtt
complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time frame: 21 days after 6 cycles of treatment (each cycle is 21 days)
progression free survival
Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Time frame: 2 year
overall survival
Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Time frame: 2 year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events
Time frame: Up to 30 days after completion of study treatment
The significance of biomarkers in tissue and plasma including cfDNA, PD-1,PD-L1
Dynamic change of the expression of PD-1, PD-L1
Time frame: through study completion,an average of 2 years
Plan to share: No
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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital