RecruitingPhase 2NCT06764017

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.

Sponsor

First Affiliated Hospital of Ningbo University

Enrollment

30 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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

Min Age: 70 YearsMax Age: 100 Years

Inclusion Criteria9

Age ≥ 70 years;
ECOG score of 0-3;
Rated as unfit or frail on the simplified geriatric assessment (sGA);
Histologically confirmed CD20-positive diffuse large B-cell lymphoma (diagnostic criteria according to WHO 2016), excluding transformed type 2 DLBCL;
Immunohistochemically confirmed positive expression of MYC and BCL2 (MYC ≥ 40%, BCL2 ≥ 50% by immunohistochemistry);
Previously untreated patients;
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;
At least one measurable lesion;
Unable to tolerate standard CHOP regimen chemotherapy or unwilling to receive chemotherapy;

Exclusion Criteria1

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.

Interventions

DRUGCHiR-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.