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
Overview
- Phase
- Phase 2
- Intervention
- Zanubrutinib, Polatuzumab Vedotin, Rituximab
- Conditions
- Diffuse Large B Cell Lymphoma
- Sponsor
- Peng Liu
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- ORR at the end of the 6th treatment cycle
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Peng Liu
Professor
Shanghai Zhongshan Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients must meet all of the following inclusion criteria to be enrolled in this study:
- •Patients with histopathologically confirmed DLBCL;
- •Patients haven't received any anti-DLBCL therapy. Corticosteroids alone is not considered as a line of treatment;
- •The age of patients ≥ 70 years old, or between 60 and 69 but with an ECOG score between 2-4;
- •Patients intolerant to standard front-line therapy, i.e. R-CHOP, or R-miniCHOP etc.
- •Good organ function;
- •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;
- •Life expectancy ≥ 6 months;
- •Sign written informed consent.
Exclusion Criteria
- •Patients with any of the following conditions cannot be enrolled in this study:
- •Patients with primary central nervous system lymphoma;
- •Patients with previous exposure to BTK inhibitors;
- •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%;
- •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)
- •HIV-infected persons;
- •HCV active infection;
- •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;
- •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;
Arms & Interventions
Elderly Treatment-naive Diffuse Large B-cell Lymphoma
Elderly Treatment-naive Diffuse Large B-cell Lymphoma
Intervention: Zanubrutinib, Polatuzumab Vedotin, Rituximab
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Proportion of patients who have achieved 2-year PFS(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))
- Safety evaluation(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)
- CRR at the end of the 6th treatment cycle(about six months from the start of ZPR)