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

A Prospective, Multicenter, Phase II Study of POLA-R-CHP in the First-line Treatment of Transformed DLBCL

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

Study Overview

• Status: Recruiting
• Conditions: Transformed Lymphoma
• Intervention / Treatment: Drug: POLA-R-CHP

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yizhen Liu, M.D., Ph.D.; Phone Number: 021-64175590; Email: aliuyz@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Yizhen Liu; Phone Number: 85100 021-64175590; Email: aliuyz@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; POLA-R-CHP	Drug: POLA-R-CHP; Pola-R-CHP is a combination of rituximab, cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin; Other Names: polatuzumab vedotin and R-CHP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year progression-free survival (PFS) assessed by imaging examination	the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason	From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year event-free survival (EFS)	the period from the date of patients sign informed consent to the observed event for any reason	From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year overall survival rate	time between the date of patients sign informed consent and the date of death or the date of last follow-up time	From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Through study completion, up to 2 years
complete remission rate assessed by imaging examination	the ratio of numbers of patients with complete response after 6 treatment cycles to all the participants	up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
tissue biomarkers	Detection of tissue DNA biomarkers in the treatment of transformed diffuse large B cell lymphoma	Throughout the treatment period, up to 2 years

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Yizhen Liu, M.D., Ph.D., Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Immunoconjugates; Polatuzumab vedotin
• Other Study ID Numbers: iNHL-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No