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

RecruitingPhase 2Ages 18 Years - anyAllThe First Affiliated Hospital with Nanjing Medica…
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In plain words

What the trial is, and whether it could suit you

Evaluation of the Safety and Efficacy of CR-CHOP Treatment in Newly Diagnosed Double-Expressor DLBCL with Other Molecular Subtypes

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📋 Eligibility rules (as published)
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
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What it tests

  • Chidamide plus R-CHOP
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Where

1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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