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A single-arm, multicenter, exploratory study of Polatuzumab Vedotin for injection in combination with Rituximab, Cyclophosphamide, Pirarubicin, and Prednisone in the initial treatment of diffuse large B-cell lymphoma

A single-arm, multicenter, exploratory study of Polatuzumab Vedotin for injection in combination with Rituximab, Cyclophosphamide, Pirarubicin, and Prednisone in the initial treatment of diffuse large B-cell lymphoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077262
Enrollment
Unknown
Registered
2023-11-02
Start date
2023-11-02
Completion date
Unknown
Last updated
2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse large B lymphoma

Interventions

Treatment:Polatuzumab Vedotin for Injection 1.8mg/Kg d0 Rituximab 375mg/m2, d0 Cyclophosphamide 750mg/m2, d1 Pirarubicin 50mg/m2, d1 Prednisone 100mg, d1-5

Sponsors

Shanxi Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Subjects fully understand and voluntarily participate in this study; 2. Histopathologically or cytologically confirmed DLBCL ; 3. Age 18-80 years old, male or female; 4. Untreated DLBCL patients; 5. There must be at least one evaluable or measurable lesion that meets Lugano2014 standards: lymph node lesion, the length of the measurable lymph node must be greater than 1.5cm; For non-lymph node lesions, the measured extra-nodal lesions should be > 1.0cm in length; 6. Bone marrow function: neutrophil count =1.5×109/L, platelet count =75×109/L, hemoglobin =80g/L (neutrophil count =1.0×109/L, platelet count =50×109/L, hemoglobin =75 g/L in patients with bone marrow involvement); 7. Liver and kidney function: serum creatinine =1.5 times the upper limit of normal value; AST and ALT =2.5 times the upper limit of normal (=5 times the upper limit of normal for patients with liver invasion); Total bilirubin =1.5 times the upper limit of normal (=3 times the upper limit of normal for patients with liver invasion); 8. Complete at least one tumor evaluation.

Exclusion criteria

Exclusion criteria: 1. Those who do not meet the above diagnostic criteria and inclusion criteria; 2. Patients with blood or immune system diseases, with other immunosuppressive therapy or trauma, or with radiotherapy; 3. Patients with active uncontrolled infections, including HIV, cytomegalovirus (CMV) infection, hepatitis B or hepatitis C (in which HBsAg or HBcAb positive but HBV-DNA negative), are also eligible for inclusion in this study and should receive prophylactic antiviral therapy. Subjects with positive anti-HCV antibody but negative HCV-RNA were also eligible for inclusion in this study); 4. Other primary malignancies associated with non-DLBCL; 5. Patients or family members are unwilling to cooperate; 6. Others, any of the following: pregnant or lactating women, patients with severe infection or persistent infectious wounds, and patients with a history of uncontrollable mental illness.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Progression free survival;Overall survival;Duration of remission;security;2 years OS rate;

Countries

CHINA

Contacts

Public ContactLiping Su

Department of Hematology, Shanxi Cancer Hospital

Sulp2003@163.com+86 138 3515 8122

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026