Chidamide Plus R-CHOP in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults diagnosed with a type of cancer called diffuse large B-cell lymphoma (DLBCL), specifically those who have a "double-expressor" subtype. This means that their cancer cells overproduce certain proteins, making the disease more aggressive. The trial combines a standard chemotherapy regimen known as R-CHOP with a drug called Chidamide to see if this combination is safe and effective for patients who have just been diagnosed. The trial is currently looking for participants aged 18 and older who meet specific health criteria, such as having measurable cancer lesions and good liver and kidney function.

If you or a loved one qualify and choose to participate, you can expect to receive the combination treatment and regular follow-up to monitor your health and any side effects. Participants will need to provide informed consent and be willing to share their treatment data. This study does not allow individuals who are currently on other clinical trials or have received prior treatment for lymphoma to join, so it's important to discuss your situation with your healthcare provider to see if this trial might be a good fit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Patients must meet all of the following inclusion criteria to be eligible for enrollment:
• • 1. ≥18 years of age;
• • 2. Diffuse large B-cell lymphoma diagnosed by pathological diagnosis according to WHO 2016 classification criteria;
• • 3. Molecular subtyping, determined through high-throughput sequencing of pathological tissue or peripheral blood, is categorized as the "Other" subtype;
• • 4. Immunohistochemistry revealed overexpression of MYC and BCL2: MYC ≥ 40%, BCL2 ≥ 50%;
• • 5. Measurable lesions identified on cross-sectional imaging through diagnostic modalities (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) are defined as the presence of at least one two-dimensional lesion with a maximum cross-sectional diameter (GTD) ≥1.5 cm, irrespective of the short-axis diameter;
• • 6. The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤2；
• • 7. Adequate hepatic function is defined as: total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN; alkaline phosphatase (ALP) ≤ 5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 35 mL/min as calculated by the Cockcroft-Gault formula;
• • 8. Voluntary participation with willingness to provide the aforementioned treatment data, accompanied by a signed and dated informed consent form.
• Exclusion Criteria:
• • Patients who meet any of the following criteria will be excluded from the study：
• • 1. Currently enrolled in another clinical trial；
• • 2. Received prior lymphoma treatment with alternative regimens before enrollment;
• • 3. Presence of concurrent malignant tumors;
• • 4. Deemed ineligible for participation by the investigator's judgment；
• • 5. Presence of severe psychiatric or neurological disorders that may impair the ability to provide informed consent and/or affect the reporting or observation of adverse events；
• • 6. Patients unable to comply with follow-up requirements；
• • 7. Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
• • 8. Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive and HBV DNA positive), HCV positive