NCT06701357 CR-CHOP+X in Previously Untreated DEL
| NCT ID | NCT06701357 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | DLBCL |
| Study Type | INTERVENTIONAL |
| Enrollment | 49 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2026-12-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a prospective, single-arm, open-label phase II clinical trial that evaluates the efficacy and safety of CR-CHOP regimen combined with different targeted drugs based on different molecular subtypes in newly diagnosed DEL patients.
Eligibility Criteria
Inclusion Criteria: * 1\. Histologically confirmed diffuse large B-cell lymphoma with CD20 positive; * 2\. MYC and BCL2 are expressed simultaneously, WHO immunohistochemical standards: MYC≥40%, BCL2 ≥50%; * 3\. Age ≥ 18 years old, ≦75 years old; * 4\. ECOG physical status score of 0, 1 or 2; * 5\. No previous history of malignant tumors; No other tumors occurred simultaneously; * 6\. Patients judged by the investigator to have a life expectancy of at least 6 months; * 7\. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure; * 8\. International prognostic Index (IPI) \>1 score. Exclusion Criteria: * 1\. Have previously received systemic or local treatment including chemotherapy; * 2\. Previously received autologous stem cell transplantation; * 3\. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ; * 4\. Accompanied by uncontrolled cardiovascular and