A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyping

Starting soon · Phase 3

Conditions studied: DLBCL - Diffuse Large B Cell Lymphoma, Double Expressor Lymphoma

In brief

Evaluate the efficacy and safety of C Pola R-CHP+X compared to CR-CHOP in the treatment of previously untreated patients with DEL

Key facts

Study ID

NCT07511114

Run by

Ruijin Hospital

People needed

156

Starts

2026-03-31

Expected to finish

2030-03-31

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;
• 2. Simultaneous expression of MYC and BCL2, according to the WHO standard for immunohistochemistry: MYC ≥ 40%, BCL2 ≥ 50%
• 3. Age ≥ 18 years old and ≤ 75 years old;
• 4. ECOG performance status score of 0, 1, or 2;
• 5. International Prognostic Index (IPI) > 1
• 6. No history of malignant tumor; no concurrent occurrence of other tumors;
• 7. Patients with an expected lifespan of at least 6 months, as determined by the researcher;
• 8. The patient or their legal representative must provide written informed consent before undergoing any special examinations or procedures in the study.

You may not qualify if…

• 1. Have previously received systemic or local treatments, including chemotherapy;
• 2. Have previously undergone autologous stem cell transplantation;
• 3. Previously had a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;
• 4. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;
• 5. Primary central nervous system lymphoma;
• 6. Left ventricular ejection fraction (LVEF) is less than or equal to 50%;
• 7. Laboratory test values during screening: (unless caused by lymphoma); A. Neutrophil count <1.5*10\^9/L; B. Platelet count < 75 x 10\^9/L; C. ALT or AST is 2 times higher than the upper limit of normal, and AKP and bilirubin are 1.5 times higher than the upper limit of normal; D. Creatinine level is higher than 1.5 times the upper limit of normal;
• 8. Other concurrent and uncontrolled medical conditions that the researcher believes will affect the patient's participation in the study.
• 9. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
• 10. Pregnant or lactating women;
• 11. Individuals infected with HIV.
• 12. Patients with positive HBsAg test results must undergo HBV DNA testing and can only be enrolled after becoming negative. Additionally, if the HBsAg test result is negative but the HBcAb test result is positive (regardless of the HBsAb status), HBV DNA testing is also required. If the result is positive, treatment must be administered until becoming negative before enrollment;

Where it is running

• No. 197 Ruijin 2nd Road, Huangpu District, Shanghai, Shanghai, Shanghai — Shanghai, China

Full record on ClinicalTrials.gov

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