💬In plain words
What the trial is, and whether it could suit you
To evaluate the efficacy and safety of Chidamide in combination with lenalidomide and rituximab (CR2) as induction therapy, followed by chidamide maintenance in responding patients with newly diagnosed elderly/unfit double-expressor DLBCL.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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