Adds targeted drugs to standard chemotherapy for untreated large B-cell lymphoma
Compares added targeted drugs with standard chemotherapy in adults with untreated lymphoma.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06803693, who can take part
Where in China
- Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT06803693
- Record updated
- 8 December 2025
- Original description
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).Read full original descriptionShow less
A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
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).
Inclusion: Signed Informed Consent Form; Age 18-75 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures; Previously untreated participants with CD20-positive DLBCL; IPI score 2-5; ECOG Performance Status of 0, 1, or 2; After 1 cycle of Pola-R-CHP, ctDNA decreased by < 3.0 LFC; Life expectancy ≥ 6 months; Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO); Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by DLBCL per the investigator for which blood product transfusions are permitted) defined as follows:; Hemoglobin ≥ 9.0 g/dL without packed RBC transfusion during 7 days before first treatment; ANC ≥ 1.0 x 10\^9/L; PLT ≥ 75 x 10\^9/L.
Exclusion: Prior solid organ transplantation or SCT; Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina; Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety; Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology)：Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HbsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing every month and appropriate antiviral therapy as indicated; Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's participation in the study; Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing)：Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA; Participants with a history of progressive multifocal leukoencephalopathy; Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):; Serum AST and ALT ≥ 2.5 x ULN; Total bilirubin ≥ 1.5 x ULN; Serum creatinine clearance < 30 mL/min (using Cockcroft-Gault formula); Contraindication to any of the individual components of Pola-RCHP or Zanubrutinib/Lenalidomide/ Decitabine; Current diagnosis of the following: Follicular lymphoma grade 3B; mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; PCNSL; History or presence of an abnormal ECG that is clinically significant in the investigator's opinion; Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of Pola-RCHP-X.