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Recruiting
NCT07884708
Chidamide, Lenalidomide, and Rituximab in Newly Diagnosed Elderly/unFit DE-DLBCL
Conditions: Double Expressor DLBCL, ELDERLY PEOPLE, Unfit, New-diagnosis DLBCL
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 38
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Location: The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu
Summary
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.
Eligibility Criteria
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 \1.5×ULN;
* HBV infection: HBsAg-positive patients: Eligible if HBV DNA \
Source: ClinicalTrials.gov (NCT07884708). StuddyBuddy aggregates publicly available trial information.