NCT06764017

CHiR Therapy for Elderly DLBCL Intolerant to Chemo

A Single-arm, Multicenter, Prospective Clinical Study of CHiR (chidamide, Zanubrutinib, and Lenalidomide) for Newly Diagnosed MYC- and BCL2-positive Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: First Affiliated Hospital of Ningbo University · Network
• Sex: All
• Age: 70 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-12-31
• Completion: 2027-08-01
• First posted: 2025-01-08
• Last updated: 2025-03-19

Locations

1 site across 1 country: China