Chidamide, Lenalidomide, and Rituximab as induction therapy for newly diagnosed elderly or unfit double-expressor DLBCL

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

In this Phase 2 study, eligible patients with untreated double-expressor DLBCL who are elderly or considered unfit receive induction therapy with chidamide, lenalidomide, and rituximab (CR2), followed by chidamide maintenance in those who respond. The trial aims to assess efficacy and safety of this regimen and to determine whether maintenance improves durability of response. Key eligibility includes age criteria, measurable disease, adequate organ function, and confirmation of MYC and BCL2 co-expression. Primary endpoints typically focus on response rate and tolerability, with secondary endpoints including progression-free survival and overall survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histopathologically confirmed, previously untreated DLBCL;
* Age ≥70 years, or ≥60 years with comorbidities (including reduced left ventricular ejection fraction, history of myocardial infarction \[\>6 months prior to enrollment\], exertional angina, arrhythmia \[Grade ≤2\], hypertension or diabetes requiring treatment), or ECOG PS ≥2 deemed ineligible for standard chemotherapy;
* At least one measurable lesion, defined as: Nodal lesion: Longest diameter \>1.5 cm, or Extranodal lesion: Longest diameter \>1.0 cm, with two perpendicular dimensions accurately measurable;
* ECOG PS ≤3;
* Estimated life expectancy ≥3 months
* MYC and BCL2 protein co-expression confirmed by immunohistochemistry (double-expressor lymphoma)
* Voluntary participation; full understanding of the study with signed informed consent; willingness and ability to comply with all study procedures

Exclusion Criteria:

* Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
* Recipients of organ transplantation;
* Uncontrolled coagulopathy or active bleeding;
* Uncontrolled cardiocerebrovascular diseases (including LVEF \<50%), connective tissue diseases, or severe active infections;
* Major organ surgery within 6 weeks prior to screening;
* Laboratory abnormalities at screening (unless lymphoma-related): Neutrophils \<1.5×10⁹/L; Platelets \<80×10⁹/L (\<50×10⁹/L if bone marrow involvement); Liver dysfunction: Total bilirubin \>1.5×ULN, ALT/AST \>2.5×ULN (or \>5×ULN with liver involvement); Renal dysfunction: Serum creatinine \>1.5×ULN;
* HBV infection: HBsAg-positive patients: Eligible if HBV DNA \<10³ IU/mL; HBsAg-negative but HBcAb-positive (regardless of HBsAb status): Eligible if HBV DNA \<10³ IU/mL;
* HIV infection;
* Central nervous system lymphoma involvement;
* Concurrent antitumor therapy (for lymphoma or other malignancies);
* Substance abuse or chronic alcoholism affecting outcome evaluation;
* Psychiatric disorders or other conditions compromising protocol compliance;
* Concurrent use of strong/moderate CYP3A4 inhibitors/inducers: Excluded if taken within 7 days prior to treatment (or \<5 half-lives);
* Inability to swallow capsules or significant gastrointestinal dysfunction (e.g., malabsorption, bariatric surgery, IBD, bowel obstruction);
* Other uncontrolled conditions deemed by investigators to: Jeopardize patient safety; Interfere with drug absorption/metabolism; Pose excessive risk to study outcomes

Where it's running

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

Study contacts

• Study coordinator: Lei Fan, Doctor
• Email: fanlei3014@126.com
• Phone: 86-13813976136

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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.