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

Recruiting now · Phase 2

Conditions studied: Chidamide, R-CHOP Chemotherapy, DLBCL - Diffuse Large B Cell Lymphoma, Double-expressor Lymphoma (DEL)

In brief

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

Key facts

Study ID

NCT06891157

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

148

Starts

2024-08-20

Expected to finish

2027-08-20

Last updated by the study team

2025-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following inclusion criteria to be eligible for enrollment:
• ≥18 years of age;
• Diffuse large B-cell lymphoma diagnosed by pathological diagnosis according to WHO 2016 classification criteria;
• Molecular subtyping, determined through high-throughput sequencing of pathological tissue or peripheral blood, is categorized as the "Other" subtype;
• Immunohistochemistry revealed overexpression of MYC and BCL2: MYC ≥ 40%, BCL2 ≥ 50%;
• 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;
• The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤2；
• 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;
• Voluntary participation with willingness to provide the aforementioned treatment data, accompanied by a signed and dated informed consent form.

You may not qualify if…

• Patients who meet any of the following criteria will be excluded from the study：
• Currently enrolled in another clinical trial；
• Received prior lymphoma treatment with alternative regimens before enrollment;
• Presence of concurrent malignant tumors;
• Deemed ineligible for participation by the investigator's judgment；
• 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；
• Patients unable to comply with follow-up requirements；
• Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
• Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive and HBV DNA positive), HCV positive

Where it is running

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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