search
Back to results

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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Zanubrutinib, Polatuzumab Vedotin, Rituximab
Sponsored by
Peng Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring Diffuse Large B Cell Lymphoma, Treatment-naive, Elderly, Zanubrutinib, Polatuzumab Vedotin, Rituximab, Efficacy, Safety

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; Known allergy to test drug; 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; Pregnant or lactating women; 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; Major surgery was performed within 4 weeks after screening; 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).

Sites / Locations

  • Zhongshan Hospital,Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elderly Treatment-naive Diffuse Large B-cell Lymphoma

Arm Description

Elderly Treatment-naive Diffuse Large B-cell Lymphoma

Outcomes

Primary Outcome Measures

ORR at the end of the 6th treatment cycle
the proportion of participants who have achieved complete or partial remission determined by the researcher.

Secondary Outcome Measures

CRR at the end of the 6th treatment cycle
the proportion of subjects evaluated by researchers to obtain CR.
Proportion of patients who have achieved 2-year PFS
Defined as the proportion of participants with a time of 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
incidence and severity of adverse events (AE) and Serious adverse event (SAE) during the study

Full Information

First Posted
June 19, 2023
Last Updated
July 10, 2023
Sponsor
Peng Liu
search

1. Study Identification

Unique Protocol Identification Number
NCT05940064
Brief Title
Prospective Clinical Study of ZPR Regimen in Elderly Treatment-naive Diffuse Large B-cell Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Anticipated)
Primary Completion Date
July 20, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peng Liu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
Diffuse Large B Cell Lymphoma, Treatment-naive, Elderly, Zanubrutinib, Polatuzumab Vedotin, Rituximab, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elderly Treatment-naive Diffuse Large B-cell Lymphoma
Arm Type
Experimental
Arm Description
Elderly Treatment-naive Diffuse Large B-cell Lymphoma
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib, Polatuzumab Vedotin, Rituximab
Other Intervention Name(s)
ZPR
Intervention Description
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
Primary Outcome Measure Information:
Title
ORR at the end of the 6th treatment cycle
Description
the proportion of participants who have achieved complete or partial remission determined by the researcher.
Time Frame
about six months from the start of ZPR
Secondary Outcome Measure Information:
Title
CRR at the end of the 6th treatment cycle
Description
the proportion of subjects evaluated by researchers to obtain CR.
Time Frame
about six months from the start of ZPR
Title
Proportion of patients who have achieved 2-year PFS
Description
Defined as the proportion of participants with a time of 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
Time Frame
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)
Title
Safety evaluation
Description
incidence and severity of adverse events (AE) and Serious adverse event (SAE) during the study
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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; Known allergy to test drug; 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; Pregnant or lactating women; 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; Major surgery was performed within 4 weeks after screening; 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Liu, Ph.D
Phone
+862164041990
Ext
2025
Email
liu.peng@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuhong Ren, M.D.
Phone
+862164041990
Ext
2225
Email
ren.yuhong@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Liu, Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital,Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Liu, Ph.D
Phone
+862164041990
Ext
2025
Email
liu.peng@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Yuhong Ren, M.D.
Phone
+862164041990
Ext
2225
Email
ren.yuhong@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Peng Liu, Ph.D
First Name & Middle Initial & Last Name & Degree
Yuhong Ren, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs