Chidamide Plus R-CHOP in Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma With Other Molecular Subtypes

Official title

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

Overview

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

• Drug Chidamide plus R-CHOP
  Chidamide Plus R-CHOP (Rituximab、Cyclophosphamide、Doxorubicin、Vincristine and Prednisone)

Primary outcome measures

• PFS [Time frame: 2 years]

Secondary outcome measures (3)

• CR rate [Time frame: up to 6 cycles (each cycle is 21 days)]
• OS [Time frame: 2 years]
• ORR [Time frame: up to 6 cycles (each cycle is 21 days)]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital with Nanjing Medical University — Nanjing

Identifiers

NCT: NCT06891157 · 2024-SR-1157

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗