Status:
RECRUITING
Chidamide Plus R-CHOP in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Chidamide
R-CHOP Chemotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Evaluation of the Safety and Efficacy of CR-CHOP Treatment in Newly Diagnosed Double-Expressor DLBCL with Other Molecular Subtypes
Detailed Description
Patients with the Other Molecular Subtype of double-expressor diffuse large B-cell lymphoma (DEL-DLBCL) demonstrate significantly poorer survival outcomes. The DEB trial demonstrated that chidamide co...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 20 2027
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06891157
Start Date
August 20 2024
End Date
August 20 2027
Last Update
March 24 2025
Active Locations (1)
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1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000