NCT05940064

Brief Summary

This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in elderly patients with treatment-naive diffuse large B-cell lymphoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

June 19, 2023

Last Update Submit

July 10, 2023

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse Large B Cell LymphomaTreatment-naiveElderlyZanubrutinibPolatuzumab VedotinRituximabEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • ORR at the end of the 6th treatment cycle

    the proportion of participants who have achieved complete or partial remission determined by the researcher.

    about six months from the start of ZPR

Secondary Outcomes (3)

  • CRR at the end of the 6th treatment cycle

    about six months from the start of ZPR

  • Proportion of patients who have achieved 2-year PFS

    2-year (from the start of treatment to the first recording of disease progression or death, based on the investigator's assessment of the first occurrence)

  • Safety evaluation

    between the first administration of the study drug and 30 days after discontinuation, or during the progression of the disease or the initiation of new anticancer treatment, whichever came first

Study Arms (1)

Elderly Treatment-naive Diffuse Large B-cell Lymphoma

EXPERIMENTAL

Elderly Treatment-naive Diffuse Large B-cell Lymphoma

Drug: Zanubrutinib, Polatuzumab Vedotin, Rituximab

Interventions

Zanubrutinib, Polatuzumab Vedotin, RituximabDRUG

Drug: Zanubrutinib, Polatuzumab Vedotin and Rituximab Zanubrutinib（Z）160 mg bid po Day 1-21; Polatuzumab Vedotin（P）1.8 mg/kg ivgtt D1; Rituximab（R）375 mg/m\^2 ivgtt D1

Also known as: ZPR
Elderly Treatment-naive Diffuse Large B-cell Lymphoma

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histopathologically confirmed DLBCL;
  • Patients haven't received any anti-DLBCL therapy. Corticosteroids alone is not considered as a line of treatment;
  • The age of patients ≥ 70 years old, or between 60 and 69 but with an ECOG score between 2-4;
  • Patients intolerant to standard front-line therapy, i.e. R-CHOP, or R-miniCHOP etc.
  • Good organ function;
  • Measurable lesions detected by radiological imaging were defined as the longest diameter of at least 1 lymph node lesion \> 1.5 cm, or the longest diameter of at least 1 extranodal lesion \> 1.0 cm, and at least 2 vertical diameters that could be accurately measured;
  • Life expectancy ≥ 6 months;
  • Sign written informed consent.

You may not qualify if:

  • Patients with any of the following conditions cannot be enrolled in this study:
  • Patients with primary central nervous system lymphoma;
  • Patients with previous exposure to BTK inhibitors;
  • Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc; Currently clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, congestive heart failure, any grade 3 or 4 heart disease defined by the New York Heart Association functional classification, or history of myocardial infarction within 6 months after screening. The left ventricular ejection fraction measured by echocardiography was \< 50%;
  • Abnormal laboratory indicators at screening (unless caused by lymphoma):
  • ANC\<1.5×10\^9/l, PLT\<80×10\^9/l 4.2 Coagulation function: INR greater than 1.5 times the upper limit of normal value; Pt and APTT were greater than 1.5 times the upper limit of normal 4.3 Liver function: ALT or ast was 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal 4.4 Renal function: creatinine was 1.5 times higher than the upper limit of normal, creatinine clearance rate was \< 60 ml/min (estimated according to Cockcroft Gault formula)
  • HIV-infected persons;
  • HCV active infection;
  • HBsAg positive patients need to be HBV DNA negative before enrollment; In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA testing is still required. If the result is positive, antiviral treatment is required, and HBV DNA is required to be negative before enrollment;
  • Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study, including psychiatric patients or other patients who are known or suspected to be unable to fully comply with the study protocol;
  • Known allergy to test drug;
  • Inability to swallow capsules or suffering from diseases that seriously affect gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction;
  • Pregnant or lactating women;
  • Corticosteroids (dose equivalent to prednisone \> 20 mg/ day) were previously given for antitumor purposes within 7 days, and chemotherapy, targeted therapy, or radiotherapy were previously received within 3 weeks, or antibody-based therapy was received within 3 weeks, or traditional Chinese medicine anticancer therapy was performed within 4 weeks;
  • Major surgery was performed within 4 weeks after screening;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

zanubrutinibpolatuzumab vedotinRituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Peng Liu, Ph.D

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Liu, Ph.D

CONTACT

+862164041990liu.peng@zs-hospital.sh.cn

Yuhong Ren, M.D.

CONTACT

+862164041990ren.yuhong@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2023

First Posted

July 11, 2023

Study Start

July 20, 2023

Primary Completion

July 20, 2025

Study Completion

December 31, 2025

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)