Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 70 to 100

Treatment for elderly patients with difficult-to-treat lymphoma

Official 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.

Run by First Affiliated Hospital of Ningbo University · NCT06764017 · Data updated 2026-11-12

This study is testing a new treatment for older patients with hard-to-treat lymphoma to see if it can help them go into remission when standard chemotherapy isn't an option.

Quick facts

PhasePhase 2
Study typeInterventional
Ages70 Years to 100 Years
SexAll
Enrollment30 (estimated)
SponsorFirst Affiliated Hospital of Ningbo University
Research network
Drugs / interventionschemotherapy
Locations1 site (Ningbo, Zhejiang)
StatusRecruiting
StartedFebruary 1, 2025
Main results expectedDecember 31, 2026
Study endsAugust 1, 2027
Registry record updatedMarch 19, 2025
Trial IDNCT06764017 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are elderly patients aged 70 and above with newly diagnosed CD20-positive DLBCL who are unfit for standard chemotherapy.

Probably not a fit

Patients with central nervous system involvement or those with HIV infection may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of CHiR therapy in elderly patients aged 70 and above who have been diagnosed with diffuse large B-cell lymphoma (DLBCL) and are unable to tolerate standard chemotherapy. The study focuses on patients with specific genetic markers (MYC and BCL2 positivity) and aims to determine the complete remission rate after eight treatment cycles. By investigating the genetic subtypes, the trial seeks to identify which patients may benefit most from this novel treatment approach.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for elderly patients with DLBCL who cannot undergo traditional chemotherapy.

How similar studies have gone: While there have been studies on treatments for DLBCL, this specific approach using CHiR therapy in elderly patients is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • The First Affiliated Hospital of Ningbo University
    Ningbo, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.