Combining Chidamide with R-CHOP for a specific type of lymphoma

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

This study is testing if adding a new drug called chidamide to standard chemotherapy can help people with a specific type of lymphoma feel better and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06891157 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of combining chidamide with R-CHOP chemotherapy in patients newly diagnosed with double-expressor diffuse large B-cell lymphoma (DEL-DLBCL) and other molecular subtypes. The study aims to improve treatment outcomes for patients who typically have poorer survival rates. By assessing the complete response rate and event-free survival, the trial seeks to determine if this combination therapy can provide significant benefits over standard treatment. Participants will undergo molecular subtyping to confirm eligibility based on specific biomarkers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with diffuse large B-cell lymphoma of the 'Other' molecular subtype, exhibiting specific overexpression of MYC and BCL2.

Not a fit: Patients with other subtypes of diffuse large B-cell lymphoma or those who do not meet the specific molecular criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival outcomes for patients with double-expressor diffuse large B-cell lymphoma.

How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for improved treatment outcomes.

Eligibility criteria

Inclusion Criteria:

* Patients must meet all of the following inclusion criteria to be eligible for enrollment:

  1. ≥18 years of age;
  2. Diffuse large B-cell lymphoma diagnosed by pathological diagnosis according to WHO 2016 classification criteria;
  3. Molecular subtyping, determined through high-throughput sequencing of pathological tissue or peripheral blood, is categorized as the "Other" subtype;
  4. Immunohistochemistry revealed overexpression of MYC and BCL2: MYC ≥ 40%, BCL2 ≥ 50%;
  5. 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;
  6. The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤2；
  7. 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;
  8. 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：

  1. Currently enrolled in another clinical trial；
  2. Received prior lymphoma treatment with alternative regimens before enrollment;
  3. Presence of concurrent malignant tumors;
  4. Deemed ineligible for participation by the investigator's judgment；
  5. 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；
  6. Patients unable to comply with follow-up requirements；
  7. Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
  8. Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive and HBV DNA positive), HCV positive

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Wei Xu, Doctor

Conditions: Chidamide, R-CHOP Chemotherapy, DLBCL - Diffuse Large B Cell Lymphoma, Double-expressor Lymphoma