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

NCT ID: NCT05940064

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

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

Study Groups

Elderly Treatment-naive Diffuse Large B-cell Lymphoma

Elderly Treatment-naive Diffuse Large B-cell Lymphoma

Group Type: EXPERIMENTAL

Zanubrutinib, Polatuzumab Vedotin, Rituximab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

ZPR

Eligibility Criteria

Inclusion Criteria

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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peng Liu

OTHER

Sponsor Role: lead

Responsible Party

Peng Liu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peng Liu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peng Liu, Ph.D

Role: CONTACT

liu.peng@zs-hospital.sh.cn

+862164041990 ext. 2025

Yuhong Ren, M.D.

Role: CONTACT

ren.yuhong@zs-hospital.sh.cn

+862164041990 ext. 2225

Facility Contacts

Peng Liu, Ph.D

Role: primary

liu.peng@zs-hospital.sh.cn

+862164041990 ext. 2025

Yuhong Ren, M.D.

Role: backup

ren.yuhong@zs-hospital.sh.cn

+862164041990 ext. 2225

Other Identifiers

SHZS-DLBCL003

Identifier Type: -

Identifier Source: org_study_id