POLA-R-CHP in the First-line Treatment of Transformed DLBCL

NCT ID: NCT06743945

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2029-12-31

Brief Summary

This study aims to evaluate efficacy and safety of POLA-R-CHP in the treatment of patients with transformed DLBCL.

Detailed Description

Patients with transformed DLBCL lack standard treatment. We intend to conduct a prospective, multicenter, phase II study in order to evaluate efficacy and safety of POLA-R-CHP as first-line treatment of patients with transformed DLBCL.

Conditions

Transformed Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

POLA-R-CHP

Group Type: EXPERIMENTAL

POLA-R-CHP

Intervention Type: DRUG

Pola-R-CHP is a combination of rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin

Interventions

POLA-R-CHP

Pola-R-CHP is a combination of rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin

Intervention Type: DRUG

Other Intervention Names

polatuzumab vedotin and R-CHP

Eligibility Criteria

Inclusion Criteria

• Age 18 -80 years old;
• Histologically confirmed transformed DLBCL;
• ECOG 0-2;
• Signed informed consent form.
• Having sufficient organ function: a) Hematopoietic function: Neutrophils ≥ 1.0 × 109/L, PLT ≥ 75 × 109/L, Hb ≥ 90g/L(unless caused by underlying disease, as judged by the investigator, such as extensive bone marrow involvement, or hypersplenism secondary to lymphoma splenic involvement); b) Liver function: bilirubin ≤1.5 times the upper limit of normal (ULN), ALT and AST<3 x ULN, serum albumin ≥ 30 g/L; c) Renal function: serum Cr<1.5 × ULN, creatinine clearance rate ≥ 50mL/min (calculated according to the standard Cockcroft Gault formula, if renal dysfunction is caused by tumor compression, creatinine clearance rate ≥ 30mL/min); d) Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography.

Exclusion Criteria

• Individuals who are allergic to human or mouse monoclonal antibodies, or known sensitivity or allergic reaction to murine products;
• Previous organ transplantation;
• Prior treatment of any condition (e.g., cancer, rheumatoid arthritis) with cytotoxic drugs within 5 years at the time of screening or prior use of any anti-CD20 antibodies;
• Evidence of uncontrolled significant comorbidities that may affect the patient's compliance with the study protocol or affect the interpretation of the study results, including significant cardiovascular disease (such as New York College of Cardiology Class III or IV heart disease, myocardial infarction within the past 6 months, unstable arrhythmia, or unstable angina) or pulmonary disease (including history of obstructive pulmonary disease and bronchospasm);
• Recent major surgery (within 4 weeks prior to enrollment), excluding diagnostic surgery;
• Known active bacterial, viral, fungal, mycobacterial, parasitic or other infections (except for fungal infections in nail beds) at the time of study enrollment or major infections within 2 weeks before the start of the first course of treatment;
• Previous radiotherapy in the mediastinum/pericardial region;
• Active chronic hepatitis B infection (defined as HBV DNA positive): If hepatitis B virus (HBV) DNA cannot be detected during screening, patients with latent or previous hepatitis B infection (defined as positive hepatitis B surface antigen or hepatitis B core total antibody) can be included in this study. The above patients must voluntarily undergo regular HBV-DNA testing and receive appropriate antiviral treatment according to regulations.
• For patients with positive hepatitis C virus (HCV) antibody serological test, only when polymerase chain reaction (PCR) shows negative HCV-RNA can participate in this study.
• Patients with active HIV and syphilis infections;
• Pregnant or lactating women;
• The researcher determined that patients are not suitable to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Yizhen Liu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yizhen Liu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yizhen Liu, M.D., Ph.D.

Role: CONTACT

aliuyz@126.com

021-64175590

Facility Contacts

Yizhen Liu

Role: primary

aliuyz@126.com

021-64175590 ext. 85100

Other Identifiers

iNHL-05

Identifier Type: -

Identifier Source: org_study_id