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RECRUITINGPHASE2

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.

NCT06764017•First Affiliated Hospital of Ningbo University

View on ClinicalTrials.gov

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

Age

70 - 100 years

Sex

ALL

Healthy Volunteers

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;

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.

Locations (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Key Dates

Start Date

February 1, 2025

Primary Completion Date

December 31, 2026

Completion Date

August 1, 2027

Last Updated

March 19, 2025

Enrollment

ESTIMATED participants

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

CHiR-DEL

DRUG

Contacts

Lixia Chief Physician

CONTACT

15968985233 slx800408@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CHiR Therapy for Elderly DLBCL Intolerant to Chemo

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

A Long-term Extension Study of PCI-32765 (Ibrutinib)

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