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Recruiting Phase 2

CHiR Therapy for Elderly DLBCL Intolerant to Chemo

NCT06764017 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-02-01
Last updated
2025-03-19

Condition(s) studied

Diffuse Large B-Cell Lymphoma

Investigational drug(s) / intervention(s)

CHiR-DEL

CHiR-DEL: Using the combined regimen of CHiR (chidamide, zanubrutinib, and lenalidomide) to treat newly diagnosed elderly patients with MYC- and BCL2-expressing positive diffuse large B-cell lymphoma (DLBCL) who are intolerant to chemotherapy.

Study summary

The objective of exploring the application of CHiR is to evaluate its therapeutic efficacy and safety in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) aged 70 and above, and to investigate the genetic subtypes that may benefit from CHiR. The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.

Eligibility

Sex
ALL
Min age
70 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 70 years; 2. ECOG score of 0-3; 3. Rated as unfit or frail on the simplified geriatric assessment (sGA); 4. Histologically confirmed CD20-positive diffuse large B-cell lymphoma (diagnostic criteria according to WHO 2016), excluding transformed type 2 DLBCL; 5. Immunohistochemically confirmed positive expression of MYC and BCL2 (MYC ≥ 40%, BCL2 ≥ 50% by immunohistochemistry); 6. Previously untreated patients; 7. Cardiac, hepatic, and renal function: creatinine \< 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 2.5 ULN; total bilirubin \< 2 ULN; 8. At least one measurable lesion; 9. Unable to tolerate standard CHOP regimen chemotherapy or unwilling to receive chemotherapy; 10. Adequate understanding and voluntary signing of the informed consent form. Exclusion Criteria: 1.Patients with central nervous system involvement at the time of onset; 2.Known human immunodeficiency virus (HIV) infection; 3.Pregnant or lactating women; 4.Other tumors requiring treatment; 5.Uncontrollable active infection; 6.Active hepatitis with HBV-DNA copy number not controlled within 2\*1000/mL despite antiviral treatment; 7.Inability to understand, comply with the study protocol, or sign the informed consent form.

Primary outcome measure(s)

  • the complete remission rate (CRR) — Each cycle consists of 21 days, with a total of 8 cycles.
    The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Ningbo University Ningbo Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06764017 on ClinicalTrials.gov ↗ ← All trials in China