Evaluating POLA-R-CHP for treating transformed DLBCL

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

This study is testing a new treatment called POLA-R-CHP to see if it can help people with transformed diffuse large B-cell lymphoma feel better and improve their outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06743945 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of POLA-R-CHP as a first-line treatment for patients with transformed diffuse large B-cell lymphoma (DLBCL), a condition that currently lacks standard treatment options. It is a prospective, multicenter, phase II trial that aims to gather data on how well this treatment works in this specific patient population. Participants will be monitored for both the effectiveness of the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed transformed DLBCL and sufficient organ function.

Not a fit: Patients with known allergies to monoclonal antibodies or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with transformed DLBCL.

How similar studies have performed: While this approach is novel for transformed DLBCL, similar studies in other lymphoma types have shown promising results.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Yizhen Liu, M.D., Ph.D. — Fudan University
• Study coordinator: Yizhen Liu, M.D., Ph.D.

Conditions Transformed Lymphoma