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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
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⁃ 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.

Locations
Other Locations
China
Zhongshan Hospital,Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Peng Liu, Ph.D
liu.peng@zs-hospital.sh.cn
+862164041990
Backup
Yuhong Ren, M.D.
ren.yuhong@zs-hospital.sh.cn
+862164041990
Time Frame
Start Date: 2023-07-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Elderly Treatment-naive Diffuse Large B-cell Lymphoma
Elderly Treatment-naive Diffuse Large B-cell Lymphoma
Sponsors
Leads: Peng Liu

This content was sourced from clinicaltrials.gov

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