Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

June 16, 2024 updated by: The First Affiliated Hospital of Soochow University

Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients in Treatment of Newly Diagnosed Untreated Non-GCB DLBCL With Extranodal Involvement.

Aim of this study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. The POLARIX study also observed an benefit in the efficacy of Polatuzumab Vedotin in first-line treatment of DLBCL patients. This study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.

Study Type

Interventional

Enrollment (Estimated)

20

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 Locations

  • China
    • Nanjing
      • Suzhou, Nanjing, China, 215000
        • The First Affiliated Hospital of Soochow University

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:

  1. Histologically confirmed Non-GCB DLBCL with extrinsic involvement；
  2. Measurable disease of at least 15mm(node)/10mm（extranodal）；
  3. ECOG performance status 0-2；
  4. Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN；
  5. Adequate bone marrow function:Platelet count (≥ 50×10^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10^9/L)
  6. Estimated survival time ≥3 months
  7. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study.

Exclusion Criteria:

  1. Accepted major surgery within 4 weeks before treatment;
  2. Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
  3. Previous history of indolent lymphoma;
  4. Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ;
  5. History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
  6. Requires treatment with a strong/medium CYP3A inducer;
  7. The previous use of anthracycline-based drugs > 150 mg/m2;
  8. Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease;
  9. HIV infection and/or active hepatitis B or active hepatitis C;
  10. Uncontrolled systemic infection;
  11. Pregnant or breasting-feeding women;
  12. According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.

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: Patients receiving Pola+ZR-CHP treatment
Drug: Polatuzumab Vedotin
1.8mg/kg/21d（d0） Intravenous infusion
Drug: Zanubrutinib
160mg bid PO（d0-d20）
Drug: Rituximab
375mg/㎡/21d（d0） Intravenous infusion
Drug: Cyclophosphamide
750mg/㎡/21d（d1） Intravenous infusion
Drug: Doxorubicin
50mg/㎡/21d（d1） Intravenous infusion
Drug: Prednisone
100mg PO （d1-d5）/21d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival（PFS）
Time Frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
The time between enrollment and tumor occurrence (in any aspect) progression or (for any reason) death
From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response rate（ORR）
Time Frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
The proportion of patients who achieved complete or partial response in efficacy evaluation at the end of treatment
From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Complete Response（CR）
Time Frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
The proportion of patients who achieved complete response in efficacy evaluation at the end of treatment
From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Duration of Response（DOR）
Time Frame: All time in the study
It refers to the time from the first assessment of a tumor as CR or PR to the second assessment as PD (Progressive Disease) or death from any cause.
All time in the study
Overall Survival
Time Frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
The time between enrollment to death(for any reason) .
From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Adverse Events(AEs)
Time Frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
All treatment-related adverse events that occur during patient treatment and follow-up.
From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory study endpoint
Time Frame: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.
Exploring the therapeutic response of subjects with different genotypes to Pola+ZR-CHP regimen using Next-generation sequencing(NGS).
From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Soochow 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 (Actual)

July 1, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 27, 2024

First Submitted That Met QC Criteria

June 16, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pola-ZR-CHP

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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