NCT06764017RecruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 19 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Jan 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06764017
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 Feb 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 70 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.