Prospective Single-arm, Single-center Clinical Study of Zanubrutinib, Polatuzumab Vedotin and Rituximab (ZPR) Regimen in Relapsed/Refractory Patients With Diffuse Large B-cell Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Zanubrutinib, Polatuzumab vedotin and Rituximab
- Conditions
- Diffuse Large B Cell Lymphoma
- Sponsor
- Peng Liu
- Enrollment
- 35
- 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 the treatment of patients with relapsed and refractory 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 the treatment of patients with relapsed and refractory diffuse large B-cell lymphoma. * Primary objective: use ORR to evaluate the effectiveness of ZPR in treating R/R DLBCL patients * Secondary objective: Evaluate the safety of ZPR treatment for R/R 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 the disease progresses or the 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/m2 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;
- •Relapsed or refractory disease, defined as
- •Disease relapse occurred after reaching disease remission (including complete response \[CR\] and partial response \[PR\]) at the end of the last treatment
- •Maintain stable disease (SD) or progressive disease (PD) at the end of the last treatment
- •The age of patients ≥ 18 years old and ≤ 80 years old;
- •The ECOG score was 0-2;
- •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;
- •Previously received ≥ 1 systemic therapy for lymphoma;
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):
- •ANC\<1.5×10\^9/l, PLT\<80×10\^9/l
- •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
- •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
- •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)
Arms & Interventions
R/R Diffuse Large B-cell Lymphoma
Intervention: Zanubrutinib, Polatuzumab vedotin and 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 years, 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)