Recruiting nowPhase 2Ages 18 Years and up
Chidamide Plus R-CHOP in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes
Sponsor: The First Affiliated Hospital with Nanjing Medical University · NCT06891157 on ClinicalTrials.gov ↗
Conditions studied
ChidamideR-CHOP ChemotherapyDLBCL - Diffuse Large B Cell LymphomaDouble-expressor Lymphoma (DEL)
What it tests
- Chidamide plus R-CHOPdrug
Where it's running1 site
1 international site
- Recruiting now
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China 210000
- Wei Xu(contact)86-25-68302182[email protected]
See the official eligibility language
Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.
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 positiveUpdated 2025-03-24 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.