Chidamide Plus R-CHOP (CR-CHOP) in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes: A Prospective, Multicenter Phase II Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Evaluation of the Safety and Efficacy of CR-CHOP Treatment in Newly Diagnosed Double-Expressor DLBCL with Other Molecular Subtypes

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Wei Xu, Doctor
xuwei10000@hotmail.com
86-2568302182
Time Frame
Start Date: 2024-08-20
Estimated Completion Date: 2027-08-20
Participants
Target number of participants: 148
Treatments
Experimental: CR-CHOP arm
Newly Diagnosed DEL Patients Receiving Chidamide plus R-CHOP(Rituximab、Cyclophosphamide、Doxorubicin、Vincristine and Prednisone) Regimen Treatment
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov