Prospective Clinical Study of ZPR Regimen in Relapsed/Refractory Diffuse Large B-cell Lymphoma

NCT05940051 | Unknown Phase 2 DMC

• 1 other identifier: SHZS-DLBCL002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Diffuse large B-cell lymphoma; Relapsed; Refractory; Polatuzumab; Zanubrutinib; Rituximab; Efficacy; Safty

Outcome Measures

Primary Outcomes (1)

• ORR at the end of the 6th treatment cycle

  the proportion of participants who have achieved complete or partial remission determined by the researcher.

  about six months from the start of ZPR

Secondary Outcomes (3)

• CRR at the end of the 6th treatment cycle

  about six months from the start of ZPR

• 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

Study Arms (1)

R/R Diffuse Large B-cell Lymphoma

EXPERIMENTAL

Drug: Zanubrutinib, Polatuzumab vedotin and Rituximab

Interventions

Zanubrutinib, Polatuzumab vedotin and Rituximab DRUG

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

R/R Diffuse Large B-cell Lymphoma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Participants who relapse after autologous stem cell transplantation may be included, provided that the transplantation treatment has been more than 6 months from the screening;
• Fresh tumor biopsies or recent tumor tissue samples must be provided (within 2 years after study entry \[signed informed consent\]);
• Fertile women must agree to use efficient contraceptive measures throughout the study and at least 90 days after the last dose of study drug. The effective forms of birth control are defined as abstinence, hysterectomy, bilateral oophorectomy without menstrual bleeding for up to 6 months, intrauterine contraception, hormonal methods such as contraceptive injection, oral contraceptives; Fertile men must undergo sterilization vasectomy or use condoms, while their female partners use the above efficient contraceptive measures;
• Life expectancy ≥ 6 months;
• Sign written informed consent.

You may not qualify if:

• 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)
• 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;

Sponsors & Collaborators

• Peng Liu: lead

Study Sites (1)

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Recurrence

Interventions

zanubrutinib; polatuzumab vedotin; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Peng Liu, Ph.D

CONTACT

+862164041990; liu.peng@zs-hospital.sh.cn

Yian Zhang, Ph.D

CONTACT

+862164041990; zhang.yi_an@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 11, 2023
• Study Start: July 20, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 30, 2025
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)