The First Affiliated Hospital with Nanjing Medical University
Phase
Phase 2
Started
2024-08-20
Last updated
2025-03-24
Condition(s) studied
ChidamideR-CHOP ChemotherapyDLBCL - Diffuse Large B Cell LymphomaDouble-expressor Lymphoma (DEL)
Investigational drug(s) / intervention(s)
Chidamide plus R-CHOP
Chidamide plus R-CHOP: Chidamide Plus R-CHOP (Rituximab、Cyclophosphamide、Doxorubicin、Vincristine and Prednisone)
Study summary
Evaluation of the Safety and Efficacy of CR-CHOP Treatment in Newly Diagnosed Double-Expressor DLBCL with Other Molecular Subtypes
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
PFS — 2 years from date of inclusion to date of progression, relapse, or death from any cause
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital with Nanjing Medical University
Nanjing
Jiangsu
Recruiting
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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