Chidamide, DLBCL - Diffuse Large B Cell Lymphoma, Double-expressor Lymphoma (DEL), R-CHOP Chemotherapy
Conditions
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 combined with R-CHOP significantly improves the complete response (CR) rate in DEL patients and shows a definitive trend toward benefit in event-free survival (EFS). Therefore, we plan to evaluate the efficacy and safety of C-R-CHOP (chidamide plus R-CHOP) in treating DLBCL patients with the DEL Other molecular subtype.
Interventions
DRUGChidamide plus R-CHOP
Chidamide Plus R-CHOP (Rituximab、Cyclophosphamide、Doxorubicin、Vincristine and Prednisone)
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 2 years | from date of inclusion to date of progression, relapse, or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CR rate | up to 6 cycles (each cycle is 21 days) | complete remission rate |
| OS | 2 years | Overall Survival: from the date of inclusion to date of death, irrespective of cause |
| ORR | up to 6 cycles (each cycle is 21 days) | The Overall Response Rate |
Countries
China
Contacts
Primary ContactWei Xu, Doctor
Outcome results
None listed