Clinical trial NCT06743945: POLA-R-CHP in the First-line Treatment of Transformed DLBCL
Official title: A Prospective, Multicenter, Phase II Study of POLA-R-CHP in the First-line Treatment of Transformed DLBCL
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Transformed Lymphoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 2-year progression-free survival (PFS) assessed by imaging examination
timeFrame: 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 outcomes:
measure: complete remission rate assessed by imaging examination
timeFrame: up to 6 months
measure: 2-year event-free survival (EFS)
timeFrame: 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
measure: 2-year overall survival rate
timeFrame: 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
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Through study completion, up to 2 years
Other outcomes:
measure: tissue biomarkers
timeFrame: Throughout the treatment period, up to 2 years
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Yizhen Liu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: