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

NCT06468943 | Enrolling By Invitation Phase 2

• 1 other identifier: Pola-ZR-CHP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Effects of Chemotherapy; Safety Issues

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival（PFS）

  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 Outcomes (5)

• Objective Response rate（ORR）

  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）

  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）

  All time in the study

• Overall Survival

  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)

  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 Outcomes (1)

• Exploratory study endpoint

  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.

Study Arms (1)

Patients receiving Pola+ZR-CHP treatment

EXPERIMENTAL

Drug: Polatuzumab Vedotin; Drug: Zanubrutinib; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone

Interventions

Polatuzumab Vedotin DRUG

1.8mg/kg/21d（d0） Intravenous infusion

Patients receiving Pola+ZR-CHP treatment

Zanubrutinib DRUG

160mg bid PO（d0-d20）

Patients receiving Pola+ZR-CHP treatment

Rituximab DRUG

375mg/㎡/21d（d0） Intravenous infusion

Patients receiving Pola+ZR-CHP treatment

Cyclophosphamide DRUG

750mg/㎡/21d（d1） Intravenous infusion

Patients receiving Pola+ZR-CHP treatment

Doxorubicin DRUG

50mg/㎡/21d（d1） Intravenous infusion

Patients receiving Pola+ZR-CHP treatment

Prednisone DRUG

100mg PO （d1-d5）/21d

Patients receiving Pola+ZR-CHP treatment

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed Non-GCB DLBCL with extrinsic involvement；
• Measurable disease of at least 15mm(node)/10mm（extranodal）；
• ECOG performance status 0-2；
• 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；
• Adequate bone marrow function:Platelet count (≥ 50×10\^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10\^9/L)
• Estimated survival time ≥3 months
• 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.

You may not qualify if:

• Accepted major surgery within 4 weeks before treatment;
• Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
• Previous history of indolent lymphoma;
• 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;
• History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
• Requires treatment with a strong/medium CYP3A inducer;
• The previous use of anthracycline-based drugs \> 150 mg/m2;
• 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;
• HIV infection and/or active hepatitis B or active hepatitis C;
• Uncontrolled systemic infection;
• Pregnant or breasting-feeding women;
• According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Nanjing, 215000, China

Location

MeSH Terms

Interventions

polatuzumab vedotin; zanubrutinib; Rituximab; Cyclophosphamide; Doxorubicin; Prednisone

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 21, 2024

Record last verified: 2024-04

Locations

CN (1)