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Clinical study of Epenemin in newly diagnosed diffuse large B-cell lymphoma with TP53 mutation

Clinical study of Epenemin in newly diagnosed diffuse large B-cell lymphoma with TP53 mutation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105726
Enrollment
Unknown
Registered
2025-07-09
Start date
2025-06-24
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Diffuse large B-cell lymphoma

Interventions

The Epenemin group:Epenamin was added to the first-line regimen

Sponsors

Department of Hematology Medicine, the First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients with newly diagnosed DLBCL. 2.Age: 18~80 years old. 3.No prior chemotherapy or radiation therapy. 4.At least one lesion that can be measured or evaluated. 5.Complete blood count, liver and kidney function were generally normal: white blood cell >=3×10^9/L, neutrophil count >=1.5×10^9/L, platelet count >=100×10^9/L; Serum creatinine =50 mL min; The total bilirubin level was 2 times the upper limit of normal, and the aspartate and alanine aminotransferase levels were 3 times the upper limit of normal. 6.Predicted survival of >=3 months.

Exclusion criteria

Exclusion criteria: 1.Patients with DLBCL with non-TP53 mutations 2.Systemic central nervous system involvement 3.Previous or concomitant malignancies, and any coexisting medical problems that may lead to poor adherence to the study protocol. 4.Does not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
Progression free survival;

Secondary

MeasureTime frame
Complete remission;Overall response rate;Overall survival;Duration of response;Disease-free survival;Event-free survival;

Countries

China

Contacts

Public ContactXiaoqiong Tang

the First Affiliated Hospital of Chongqing Medical University

357618286@qq.com+86 136 3833 2366

Outcome results

None listed

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