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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 70 Years to 100 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | First Affiliated Hospital of Ningbo University Research network |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ningbo, Zhejiang) |
| Status | Recruiting |
| Started | February 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | August 1, 2027 |
| Registry record updated | March 19, 2025 |
| Trial ID | NCT06764017 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
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The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Lixia Chief Physician
- Email: slx800408@163.com
- Phone: 15968985233
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL
This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.
-
Glofitamab combo vs Rituximab combo with chemo for relapsed/refractory DLBCL
This study tests whether glofitamab with chemotherapy (JS203-GemOx) helps patients with relapsed or refractory DLBCL more than rituximab with chemotherapy.
-
Non-Hodgkin Lymphoma Sample Collection for MRD Testing
This study tests a blood-based and tissue-based approach to see if a molecular residual disease test can detect lingering cancer in adults with aggressive NHL who are starting standard therapy.
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External beam radiation followed by bispecific antibody therapy for relapsed or refractory DLBCL
This study tests whether giving targeted radiation first, then bispecific antibodies (epcoritamab or glofitamab), is tolerable for adults with relapsed or refractory diffuse large B-cell lymphoma.
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Chidamide maintenance for MRD-positive double-expressor DLBCL in first remission
This study tests whether giving chidamide as maintenance therapy can help people with double-expressor DLBCL who have complete remission but still have MRD detected in their blood.
-
Cognitive changes in people treated for diffuse large B‑cell lymphoma
This study tests whether adults with newly diagnosed diffuse large B‑cell lymphoma experience cognitive changes during and after standard chemotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.