RecruitingPhase 2

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

China148 participantsStarted 2024-08-20

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥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.

✕. Currently enrolled in another clinical trial；
✕. Received prior lymphoma treatment with alternative regimens before enrollment;

PFS

Timeframe: 2 years

NCT IDNCT06891157

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-20

Wei Xu, Doctor

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥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.

✕. Currently enrolled in another clinical trial；
✕. Received prior lymphoma treatment with alternative regimens before enrollment;