Treatment for elderly patients with difficult-to-treat lymphoma
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.
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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 70 Years to 100 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Ningbo University Research network |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT06764017 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 70 and above with newly diagnosed CD20-positive DLBCL who are unfit for standard chemotherapy.
Not a fit: Patients with central nervous system involvement or those with HIV infection may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ningbo, Zhejiang
- The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Lixia Chief Physician
- Email: slx800408@163.com
- Phone: 15968985233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.