Prospective Clinical Study of ZPR Regimen in Elderly Treatment-naive Diffuse Large B-cell Lymphoma

July 10, 2023 updated by: Peng Liu

Prospective Single-arm, Single-center Clinical Study of Zanubrutinib, Polatuzumab Vedotin and Rituximab (ZPR) Regimen in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Primary objective: use ORR to evaluate the efficacy of ZPR in treating elderly treatment-naive DLBCL patients

Secondary objective: Evaluate the safety of ZPR treatment for elderly treatment-naive DLBCL patients

The subjects received 6 cycles of ZPR regimen, one cycle every 21 days. Then Zanubrutinib alone will continue to be used until Zanubrutinib has been used for 1 year or disease progression or intolerable adverse effects, death, withdrawal of informed consent or study termination.

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital,Fudan University
        • Contact:
        • Principal Investigator:
          • Peng Liu, Ph.D
        • Contact:
        • Sub-Investigator:
          • Yuhong Ren, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be enrolled in this study:

  1. Patients with histopathologically confirmed DLBCL;
  2. Patients haven't received any anti-DLBCL therapy. Corticosteroids alone is not considered as a line of treatment;
  3. The age of patients ≥ 70 years old, or between 60 and 69 but with an ECOG score between 2-4;
  4. Patients intolerant to standard front-line therapy, i.e. R-CHOP, or R-miniCHOP etc.
  5. Good organ function;
  6. 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;
  7. Life expectancy ≥ 6 months;
  8. Sign written informed consent.

Exclusion Criteria:

Patients with any of the following conditions cannot be enrolled in this study:

  1. Patients with primary central nervous system lymphoma;
  2. Patients with previous exposure to BTK inhibitors;
  3. 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%;

  4. Abnormal laboratory indicators at screening (unless caused by lymphoma):

    4.1 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)

  5. HIV-infected persons;
  6. HCV active infection;
  7. 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;
  8. 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;
  9. Known allergy to test drug;
  10. 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;
  11. Pregnant or lactating women;
  12. 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;
  13. Major surgery was performed within 4 weeks after screening;
  14. Sustained treatment with potent and moderate CYP3A inhibitors or CYP3A inducers is needed. Patients could not be enrolled if they had taken potent and moderate CYP3A inhibitors or CYP3A inducers within 7 days before the first administration of study drugs (or had taken these drugs for no more than 5 half-lives).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elderly Treatment-naive Diffuse Large B-cell Lymphoma
Drug: Zanubrutinib, Polatuzumab Vedotin, Rituximab
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
Other Names:
  • ZPR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR at the end of the 6th treatment cycle
Time Frame: about six months from the start of ZPR
the proportion of participants who have achieved complete or partial remission determined by the researcher.
about six months from the start of ZPR

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRR at the end of the 6th treatment cycle
Time Frame: about six months from the start of ZPR
the proportion of subjects evaluated by researchers to obtain CR.
about six months from the start of ZPR
Safety evaluation
Time Frame: 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
incidence and severity of adverse events (AE) and Serious adverse event (SAE) during the study
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
Proportion of patients who have achieved 2-year PFS
Time Frame: 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)
Defined as the proportion of participants with a time of 2 years from the start of treatment to the first recording of disease progression or death, based on the investigator's assessment of the first occurrence
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peng Liu

Investigators

  • Principal Investigator: Peng Liu, Ph.D, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2023

Primary Completion (Estimated)

July 20, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHZS-DLBCL003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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