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

NCT04705129 | Unknown Phase 2

• 1 other identifier: RJ-PMBCL-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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-positive diffuse large B-cell lymphoma.

Conditions

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

Keywords

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

Outcome Measures

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

  21 days after 6 cycles of treatment (each cycle is 21 days)

Secondary Outcomes (3)

• progression free survival

  2 year

• overall survival

  2 year

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  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

  through study completion，an average of 2 years

Study Arms (1)

zanubrutinib+Tislelizumab

EXPERIMENTAL

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

Drug: Zanubrutinib; Drug: Tislelizumab

Interventions

Zanubrutinib DRUG

160mg Bid, D1-21, po

zanubrutinib+Tislelizumab

Tislelizumab DRUG

200mg, D1, ivgtt

zanubrutinib+Tislelizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic

Interventions

zanubrutinib; tislelizumab

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Weili Zhao, PhD, MD

  Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

Weili Zhao, PhD, MD

CONTACT

+862164370045; zwl_trial@163.com

Pengpeng Xu, PhD, MD

CONTACT

+862164370045; pengpeng_xu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director, Hematology Department

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 12, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)