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A Clinical Study on Individualized Dynamic Frailty-Adjusted Therapy (DynaFIT) for Elderly Patients with Diffuse Large B-Cell Lymphoma

A Clinical Study on Individualized Dynamic Frailty-Adjusted Therapy (DynaFIT) for Elderly Patients with Diffuse Large B-Cell Lymphoma: A Prospective Single-Arm, Single-Center Clinical Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103929
Enrollment
Unknown
Registered
2025-06-09
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffused large B cell lymphoma-NOS

Interventions

sigle arm:Individualized Dynamic Frailty-Adjusted Therapy

Sponsors

Xi'an Jiaotong University Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The subject fully understands this study, voluntarily participates, and signs the informed consent form (ICF). 2. Age >= 60 years, regardless of gender. 3. Patients pathologically diagnosed with diffuse large B-cell lymphoma (not otherwise specified, DLBCL-NOS). 4. Laboratory tests meet the following criteria: Total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 times ULN. Imaging studies exclude severe infections.

Exclusion criteria

Exclusion criteria: 1. A history of severe allergy to any drug in the regimen (rituximab, cyclophosphamide, doxorubicin, vindesine, prednisone, lenalidomide). 2. Intolerance to any drug in the regimen. 3. Bacterial, fungal, or viral infections requiring systemic treatment within 1 week prior to the administration of the study drugs. 4. Severe cardiac disease or cardiac dysfunction, as determined by the investigator, making the use of anthracyclines unsuitable; or prior use of high-dose anthracyclines for other diseases, making it impossible to continue full-dose administration according to the study protocol. 5. Any other condition deemed by the investigator to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
The comprehensive complete remission rate(CR),partial remission rate(PR),and overall response rate(ORR,=PR)after 4 courses and 8 courses of treatment.;safety;

Secondary

MeasureTime frame
Changes in the IACA index during the treatment;relapse free survival;overall survival;progression free survival;

Countries

China

Contacts

Public ContactShan Meng

Xi'an Jiaotong University Second Affiliated Hospital

101xyz2@163.com+86 29 87679459

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026