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

NCT ID: NCT06468943

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2028-05-01

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.

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.

Conditions

Effects of Chemotherapy; Safety Issues

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients receiving Pola+ZR-CHP treatment

Group Type: EXPERIMENTAL

Polatuzumab Vedotin

Intervention Type: DRUG

1.8mg/kg/21d（d0） Intravenous infusion

Zanubrutinib

Intervention Type: DRUG

160mg bid PO（d0-d20）

Rituximab

Intervention Type: DRUG

375mg/㎡/21d（d0） Intravenous infusion

Cyclophosphamide

Intervention Type: DRUG

750mg/㎡/21d（d1） Intravenous infusion

Doxorubicin

Intervention Type: DRUG

50mg/㎡/21d（d1） Intravenous infusion

Prednisone

Intervention Type: DRUG

100mg PO （d1-d5）/21d

Interventions

Polatuzumab Vedotin

1.8mg/kg/21d（d0） Intravenous infusion

Intervention Type: DRUG

Zanubrutinib

160mg bid PO（d0-d20）

Intervention Type: DRUG

Rituximab

375mg/㎡/21d（d0） Intravenous infusion

Intervention Type: DRUG

Cyclophosphamide

750mg/㎡/21d（d1） Intravenous infusion

Intervention Type: DRUG

Doxorubicin

50mg/㎡/21d（d1） Intravenous infusion

Intervention Type: DRUG

Prednisone

100mg PO （d1-d5）/21d

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Nanjing, China

Countries

China

Other Identifiers

Pola-ZR-CHP

Identifier Type: -

Identifier Source: org_study_id