Mechanism Investigation of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP) Regimen or Tucidinostat Plus R-CHOP (CR-CHOP) Regimen in the Treatment of BCL2/MYC Protein Double Expressor Lymphoma

Ruijin Hospital0 sites400 target enrollmentOctober 30, 2024

ConditionsDiffuse Large B Cell Lymphoma (DLBCL)Double Expressor Lymphoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diffuse Large B Cell Lymphoma (DLBCL)
Sponsor: Ruijin Hospital
Enrollment: 400
Primary Endpoint: Event Free Survival (EFS)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is trying to explore the mechanism of R-CHOP regimen or tucidinostat plus R-CHOP (CR-CHOP) regimen in the treatment of BCL2/MYC protein double expressor lymphoma.

Detailed Description

Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. This study is trying to explore the mechanism of R-CHOP regimen or tucidinostat plus R-CHOP (CR-CHOP) regimen in the treatment of BCL2/MYC protein double expressor lymphoma. We will retain the hematoxylin and eosin (HE) -stained slides of tumor tissue, immunohistochemical staining slides for BCL2 and MYC, as well as FFPE (Formalin Fixed Paraffin Embedded) tissues. We will conduct biological tests via digital pathology and DNA sequencing, aiming to uncover the pathogenic mechanism of double expressor lymphoma and the potential therapeutic targets of CR-CHOP regimen.

Registry

clinicaltrials.gov

Start Date

October 30, 2024

End Date

December 30, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Principal Investigator

Zhao Weili

Professor

Ruijin Hospital

Eligibility Criteria

Inclusion Criteria

•Each potential subject must satisfy all of the following criteria to be enrolled in the study.
•Male or female, age ≥ 18 years and ≤80 years. No prior treatment for diffuse large B cell lymphoma(DLBCL), including hemotherapy, immunotherapy; radiotherapy (excluding local radiotherapy); monoclonal antibody therapy; surgical treatment (excluding biopsy) Histological or cytological confirmation of DLBCL CD20-positive DLBCL; Myc≥40% as well as Bcl-2≥50% through immunohistochemistry; Not with double (BCL-2 and c-MYC gene rearrangement) or triple (BCL-2, BCL-6, and c-MYC gene rearrangement) hit by FISH.
•The verification of DLBCL will be based on local pathology report.15-20 unstained slides must be sent to the central laboratory for retrospective confirmation.
•4.At least one positive lesion according to the Lugano Classification by fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography(CT).
•5.Lymphoma International PrognosisIndex (IPI) score of 2,3,
•6.Eastern Cooperative Oncology Group performance status grade of 0, 1, or
•7.Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry):
•(1)Hematology values:Hemoglobin (Hb)≥90g/L ; Absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L (2)Biochemical values: Serum creatinine ≤1.5×upper limit of normal(ULN); Total bilirubin ≤1.5 × ULN; Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤2.5×ULN(ALT,AST≦5×ULN if liver involved).
•8.Expected survival≥6 months. 9.All patients must have signed an informed consent document.

Exclusion Criteria

•Any potential subject who meets any of the following criteria will be excluded from participating in the study.
•Presence of CNS involvement. Patients with primary DLBCL of the central nervous system (CNS),or secondary lymphoma of the central nervous system, or Primary mediastinal (thymic) large B-cell lymphoma, or Primary effusion lymphoma, or B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma, or Primary cutaneous DLBCL, leg type, or indolent lymphoma, or Burkitt lymphoma, or EBV-positive mucocutaneous ulcer, or DLBCL associated with chronic inflammation, or Lymphomatoid granulomatosis, or Intravascular large B-cell lymphoma, or ALK-positive large B-cell lymphoma, or Plasmablastic lymphoma, or HHV8-positive DLBCL, NOS, or primary testicular DLBCL.
•Patients with transformed lymphoma. History of organ transplantation or hematopoietic stem cell transplantation. Patients planned for autologous or allogeneic transplant as consolidation in first line.
•Patients with any other malignancy, except patients with a history of curatively treated basal or squamous cell carcinoma or in situ carcinoma of the cervix at any time prior to the study are eligible.
•Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody within 5 years of the start of Cycle
•Prior use of any monoclonal antibody within 3 months of the start of Cycle
•Any investigational therapy within 3 months prior to the start of Cycle
•History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
•Contraindication to any of the individual components of CHOP.
•Corticosteroid use \> 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control:

Outcomes

Primary Outcomes

Event Free Survival (EFS)

Time Frame: Up to approximately 5 years

Defined as the duration from the date of randomization to the date of disease progression, relapse from CR , initiation of subsequent systemic antilymphoma therapy for residual disease, or death, whichever occurs first.