Newly diagnosed diffuse large B-cell lymphoma with MYC/BCL2 double expression
Conditions
Interventions
Experimental group:Chidamide combined with reduced-dose R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone)
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years and = 40%, BCL2 >= 50%. (3) If the subject has undergone FISH testing, this criterion must be met. Not "double-hit" or "triple-hit" lymphoma: FISH testing should show no evidence of "MYC and BCL2 rearrangement," "MYC and BCL6 rearrangement," or "MYC and BCL2 and BCL6 rearrangement." 4. Presence of at least one evaluable or measurable lesion according to the Lugano 2014 criteria. 5. International Prognostic Index (IPI) score > 1. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 7. At screening, laboratory tests must meet the following criteria, unless the investigator judges the abnormalities to be caused by lymphoma (no corrective or supportive treatment for the parameters below within 2 weeks before assessment): (1) Hematology: Hemoglobin (Hb) >= 90 g/L, Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L, Platelet Count (PLT) >=90 × 10^9/L. (2) Biochemistry: Serum creatinine (Cr) <= 1.5 × Upper Limit of Normal (ULN); Total Bilirubin (TBIL) <= 1.5 × ULN; Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) <= 2.5 × ULN (for cases with liver metastasis: <= 5 × ULN). 8. The investigator judges that the subject has a life expectancy of at least 6 months. 9. Understands and voluntarily signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of central nervous system (CNS) metastasis or leptomeningeal metastasis. 2. Prior or current diagnosis of primary CNS DLBCL, primary mediastinal (thymic) large B-cell lymphoma, primary effusion DLBCL, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma), primary cutaneous DLBCL, indolent lymphoma, Burkitt lymphoma, EBV-positive mucocutaneous ulcer, chronic inflammation-associated DLBCL, lymphomatoid granulomatosis, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, plasmablastic lymphoma, HHV8+ DLBCL, or primary testicular lymphoma. 3. Transformed lymphoma, i.e., lymphoma transformed from other lymphoma types such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma. 4. Prior history of organ transplantation or hematopoietic stem cell transplantation. 5. Patients planned to undergo hematopoietic stem cell transplantation as consolidation therapy after achieving CR with the investigational treatment. 6. Prior or current presence of other malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. 7. Received cytotoxic drugs for other diseases (e.g., rheumatoid arthritis) within 5 years prior to the first dose, or prior use of any anti-CD20 antibody. 8. Use of any monoclonal antibody within 3 months prior to the first dose. 9. Participation in other interventional clinical trials within 3 months prior to the first dose. 10. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergic reaction to murine products. 11. Contraindication to any component of the CHOP regimen. 12. Corticosteroid use > 30 mg/day prednisone or equivalent for purposes other than lymphoma symptom control. The following conditions allowing enrollment must meet the corresponding requirements: (1) If receiving corticosteroid therapy, i.e., 470 ms (female) or > 450 ms (male) at screening. (4) Coronary artery disease requiring medication and with symptoms at screening. (5) Other cardiovascular diseases deemed unsuitable for enrollment by the investigator. 15. History of interstitial lung disease (ILD), such as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;Progression-free survival period;Disease-free survival period;Overall survival period;Safety indicators (adverse events, AE); | — |
Countries
China
Contacts
Public ContactYao Liu
Chongqing University Cancer Hospital
Outcome results
None listed