NCT07493148 Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL
| NCT ID | NCT07493148 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ou Bai, MD/PHD |
| Condition | Diffuse Large B-Cell Lymphoma (DLBCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2029-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-04-30 with a primary completion date of 2029-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Efficacy and safety of chidamide in combination with the R-mini CHOP regimen, followed by chidamide plus CD20 monoclonal antibody as maintenance therapy, in elderly patients with newly diagnosed MYC/BCL2 double-expressor DLBCL.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 70 years; 2. No prior treatment for DLBCL; 3. Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): ① Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), and CD20-positive; ② "MYC/BCL2 double-expressor": Immunohistochemistry (IHC) per WHO criteria: MYC ≥ 40%, and BCL2 ≥ 50%; ③ Non-"double-hit" or "triple-hit" lymphoma; 4. At least one 18F-fluorodeoxyglucose (18FDG)-avid lesion on positron emission tomography-computed tomography (PET-CT) according to the 2014 Lugano classification for Hodgkin and non-Hodgkin lymphoma; 5. International Prognostic Index (IPI) score \> 1; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 7. At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the indicators below within 2 weeks prior to assessment): ① Hematology: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; ② Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis); 8. Life expectancy ≥ 6 months; 9. Understand and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Central nervous system (CNS) involvement; 2. Transformed lymphoma, i.e., lymphoma transformed from other lymphoma types such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma; specific subtypes of DLBCL (e.g., primary CNS DLBCL, etc.); 3. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases; 4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergic reactions to murine products; contraindications to any component of the CHOP regimen or chidamide; 5. HIV/HCV infection; 6. If HBsAg is positive, HBV DNA testing is required; patients with negative DNA may be enrolled. If HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV DNA testing is required; patients with negative DNA may be enrolled. 7. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases; 8. Inability to comply with the study protocol due to psychiatric or other unknown reasons; 9. For female patients of childbearing potential or male patients with partners of childbearing potential, unwillingness or inability to use effective contraception throughout the study treatment period and for 12 weeks after the last dose of chidamide or 12 months after the last dose of rituximab, whichever is longer; pregnant or breastfeeding women; 10. Other conditions deemed unsuitable for participation in this trial.
Contact & Investigator
Ou Bai, PHD
PRINCIPAL INVESTIGATOR
The First Bethune Hospital of Jilin University
Frequently Asked Questions
Who can join the NCT07493148 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Diffuse Large B-Cell Lymphoma (DLBCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07493148 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07493148 currently recruiting?
Yes, NCT07493148 is actively recruiting participants. Contact the research team at oubai16@163.com for enrollment information.
Where is the NCT07493148 trial being conducted?
This trial is being conducted at Changchun, China.
Who is sponsoring the NCT07493148 clinical trial?
NCT07493148 is sponsored by Ou Bai, MD/PHD. The principal investigator is Ou Bai, PHD at The First Bethune Hospital of Jilin University. The trial plans to enroll 50 participants.