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Status unknownNCT04705129Updated Mar 30, 2021

Zanubrutinib Combined With Tislelizumab in the Treatment of r/r PMBCL and EBV+ DLBCL

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 sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Primary Mediastinal Large B Cell Lymphoma
  • EBV-Positive DLBCL, Nos

Keywords

  • Primary Mediastinal Large B Cell Lymphoma
  • EBV-Positive DLBCL, nos
  • targeted therapy
03

In context

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 →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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-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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    zanubrutinib+Tislelizumab

    Zanubrutinib 160mg Bid, D1-21, po;Tislelizumab 200mg, D1, ivgtt

    Drug: Zanubrutinib · Drug: Tislelizumab

Interventions

  • DrugZanubrutinib

    160mg Bid, D1-21, po

  • DrugTislelizumab

    200mg, D1, ivgtt

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

Other outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Ruijin Hospital
    Shanghai, Shanghai 200020, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04705129
Lead sponsor
Ruijin Hospital
Responsible party
Zhao Weili (First Deputy Director, Hematology Department, Ruijin Hospital) — Principal investigator
First posted
Jan 12, 2021
Start date
Jan 1, 2021
Primary completion
Jan 1, 2023 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Mar 30, 2021

Study contacts

Weili Zhao, PhD, MD
Contact
zwl_trial@163.com
+862164370045
Pengpeng Xu, PhD, MD
Contact
pengpeng_xu@126.com
+862164370045
Weili Zhao, PhD, MD
study chair · Ruijin Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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