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NCT Number: NCT06764017

CHiR Therapy for Elderly DLBCL Intolerant to Chemo

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.

Recruiting

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Key information

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 3150101, China

Location status: Recruiting

Location contact

Shaoying Chen

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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.

Treatment and study plan

CHiR-DEL

Drug

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.

Primary outcomes

  1. the complete remission rate (CRR)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lixia Chief Physician

CONTACT

[email protected]

15968985233

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Ningbo University

Network

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 8, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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