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Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy
NCT06758037 · First Affiliated Hospital of Ningbo University
In plain English
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Official title
A Single-arm, Multicenter Phase II Clinical Study of HiR+X Therapy for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy, Guided by Molecular Subtyping and Clinical Characteristics.
About this study
To explore the application of HiR (Zebtorizumab, Lenalidomide) + X (targeted drug) guided by NGS molecular typing, the aim is to assess the therapeutic efficacy and safety in newly diagnosed unfit or frail elderly patients with DLBCL aged ≥70 years, and to investigate the genetic subtypes that may benefit from HiR-X.
Eligibility criteria
Inclusion Criteria:
1. Age ≥ 70 years;
2. ECOG score 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. Previously untreated, newly diagnosed patients;
6. Cardiac, hepatic, and renal function: creatinine \< 2 times the upper limit of normal (ULN); ALT (alanine aminotransferase) / AST (aspartate aminotransferase) \< 2.5 x ULN; total bilirubin \< 2 x ULN;
7. At least one measurable lesion;
8. Intolerance to standard CHOP chemotherapy regimen or unwillingness to receive chemotherapy;
9. Sufficient understanding and voluntary signing of the informed consent form.
Exclusion Criteria:
1. Patients with central nervous system involvement at the onset of the disease;
2. Known human immunodeficiency virus (HIV) infection;
3. Pregnant or lactating women;
4. Other tumors requiring treatment;
5. Uncontrolled active infection;
6. Active hepatitis with HBV-DNA copy number unable to be controlled within 2000/mL despite antiviral treatment;
7. Individuals who cannot understand, comply with the study protocol, or sign the informed consent form.
Study design
Enrollment target: 50 participants
Allocation: na
Masking: none
Age groups: older_adult
Timeline
Starts: 2025-01-15
Estimated completion: 2027-06-30
Last updated: 2025-03-18
Interventions
Drug: Drug therapy
Primary outcomes
- • Complete response rate (CR) at the end of 6 cycles (Each cycle consists of 21 days, with a total of 6 cycles.)
Sponsor
First Affiliated Hospital of Ningbo University · network
All locations (1)
The First Affiliated Hospital of Ningbo UniversityRecruiting
Ningbo, Zhejiang, China