Actively Recruiting

Phase 2
Age: 70Years - 100Years
All Genders
NCT06764017

CHiR Therapy for Elderly DLBCL Intolerant to Chemo

Led by First Affiliated Hospital of Ningbo University · Updated on 2025-03-19

30

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CHiR Therapy for Elderly DLBCL Intolerant to Chemo

Who Can Participate

Age: 70Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China, 3150101

Actively Recruiting

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Research Team

L

Lixia Chief Physician

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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