Actively Recruiting
Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
Led by Ruijin Hospital · Updated on 2025-12-08
152
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
CONDITIONS
Official Title
Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed Informed Consent Form
- Age 18 to 75 years at the time of consent and willing to follow study procedures
- Previously untreated with CD20-positive diffuse large B-cell lymphoma
- International Prognostic Index (IPI) score between 2 and 5
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- After 1 cycle of Pola-R-CHP, circulating tumor DNA decreased by less than 3.0 log fold change
- Life expectancy of at least 6 months
- Left ventricular ejection fraction (LVEF) of 50% or higher on cardiac MUGA scan or echocardiogram
- Adequate blood counts unless due to lymphoma involvement, including hemoglobin 9.0 g/dL or higher without recent transfusion, absolute neutrophil count at least 1.0 x 10^9/L, and platelets at least 75 x 10^9/L
You will not qualify if you...
- Allergy or contraindication to any component of Pola-RCHP or the targeted agents zanubrutinib, lenalidomide, or decitabine
- Previous solid organ or stem cell transplant
- Current diagnosis of follicular lymphoma grade 3B, mediastinal grey zone lymphoma, primary mediastinal large B-cell lymphoma, Burkitt lymphoma, or primary central nervous system lymphoma
- Significant cardiovascular disease including NYHA Class III or IV, recent myocardial infarction within 6 months, unstable arrhythmias, or unstable angina
- Abnormal ECG considered clinically significant by the investigator
- Liver enzymes (AST or ALT) at least 2.5 times the upper limit of normal or total bilirubin at least 1.5 times the upper limit of normal
- Kidney function with creatinine clearance below 30 mL/min
- Any active infection within 7 days before starting treatment
- Positive hepatitis B surface antigen test (HBsAg); patients with prior hepatitis B infection must have undetectable HBV DNA and comply with monthly testing and antiviral treatment if needed
- Positive hepatitis C antibody test unless PCR is negative for HCV RNA
- History of progressive multifocal leukoencephalopathy
- Pregnant or breastfeeding women or intent to become pregnant during the study or within 12 months after treatment
- Other uncontrolled medical conditions that may affect participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
W
Weili Zhao
CONTACT
P
Pengpeng Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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