Clinical trial · Interventional
A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyping
A Prospective, Open-label, Multicenter, Randomized Controlled Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated Double-expression Diffuse Large B-cell Lymphoma Under the Guidance of Genotyping
NCT07511114CI-TRIAL-00107330not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the efficacy and safety of C Pola R-CHP+X compared to CR-CHOP in the treatment of previously untreated patients with DEL
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL - Diffuse Large B Cell Lymphoma | Interdigitating Dendritic Cell Sarcoma | PROBABILISTIC | 0.70 |
| Double Expressor Lymphoma | Double-Expressor Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-Pola-R-CHP+X | Drug | — | UNRESOLVED |
| CR-CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Innovative Treatment Group
- description
- The experimental group first received one course of CR-CHOP regimen, and then the subsequent treatment was determined based on whether the ctDNA LFC reached 3 after one cycle of CR-CHOP treatment. Perform ctDNA detection at C1D14, and continue CR-CHOP treatment for patients with C1D14 ctDNA LFC ≥ 3 until 6 cycles. For patients with C1D14 ctDNA LFC \< 3, stratification based on gene subtypes is conducted into C1, C2-3, and TP53mut types, which determines the medication for the remaining 5 cycles. For C1 type, PD1 inhibitors are added; for C2 and C3 types, BTK inhibitors are added; for TP53mut type, decitabine is added.
- interventionNames
- Drug: C-Pola-R-CHP+X
- type
- ACTIVE_COMPARATOR
- label
- CR-CHOP
- interventionNames
- Drug: CR-CHOP
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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;
References
Publications (0)
Data not yet available
No reference posted for this study.