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NCT06891157RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 24 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
148 (estimated)
First submitted
13 Mar 2025
Start date
20 Aug 2024
Primary completion date
20 Aug 2027
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT06891157

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 148
  • From 20 Aug 2024 to the primary completion date, 20 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital with Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.