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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Wei Xu, Doctor
• Email: xuwei10000@hotmail.com
• Phone: 86-2568302182

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

  This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.

  Recruiting at 2 sites The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 1 other locations · NCT07778212

• Hypofractionated Radiotherapy plus GM-CSF, Pomalidomide and Glofitamab for Newly Diagnosed PCNS-DLBCL

  This study tests a combination therapy—hypofractionated radiotherapy with GM-CSF, pomalidomide, and glofitamab—for adults newly diagnosed with primary CNS DLBCL to see if it helps control the disease.

  Recruiting Phase 2 The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07749365

• Modified DHAP vs Standard DHAP in relapsed/refractory DLBCL

  This phase 3 trial tests whether a split, lower-dose version of DHAP is as effective as the standard regimen for adults with relapsed or refractory DLBCL and tries to reduce toxicities.

  Recruiting Phase 3 King Edward Medical University · Lahore, Punjab Province · NCT07739654

• Orelabrutinib plus standard immunochemotherapy with or without auto-HSCT for newly diagnosed DLBCL

  This study tests whether adding orelabrutinib to standard chemotherapy, with or without autologous stem cell transplantation, helps newly diagnosed DLBCL patients.

  Recruiting Phase 2 The Affiliated Hospital of Xuzhou Medical University · Xuzhou, Jiangsu · NCT07680933

• SCTB35 with Gemcitabine and Oxaliplatin in relapsed or refractory DLBCL

  This trial tests whether SCTB35 added to gemcitabine and oxaliplatin helps people with relapsed or refractory diffuse large B-cell lymphoma stay disease-free longer compared with rituximab plus gemcitabine and oxaliplatin.

  Recruiting Phase 3 Sinocelltech Ltd. · Beijing · NCT07570823

• CT1182 CAR‑T infusion for adults with relapsed or refractory B‑cell non‑Hodgkin lymphoma

  This trial tests whether a CT1182 CAR‑T cell infusion is safe and can help adults 18–75 with relapsed or refractory B‑cell non‑Hodgkin lymphoma.

  Recruiting Early Phase 1 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07548697

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.