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A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of teniposide combined with RCHOP in newly diagnosed diffuse large B-cell lymphoma patients with high risk of central nervous system relapse

A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of teniposide combined with RCHOP in newly diagnosed diffuse large B-cell lymphoma patients with high risk of central nervous system relapse

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099874
Enrollment
Unknown
Registered
2025-03-31
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

study group:Teniposide 60mg/m^2 D1-3 Rituximab 375mg/m^2 D0 cyclophosphamide 750mg/m^2

Sponsors

The first affiliated hospital Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. According to the fifth edition of the WHO classification of lymphohematopoietic system tumors, the patient was pathologically diagnosed with diffuse large B-cell lymphoma; 2. Age 18-65 years old; 3. Have not received chemotherapy and radiotherapy; 4. Physical condition (ECOG. score 0-2 points 5. CNS-IPI score of 4-6 points, involving testicles, breast, tumor tissues CD5 or intravascular large B patients at the time of initial diagnosis; 6. PET-CT or CT/MRI showing at least one two-dimensional measurable lesion (longest diameter> 1.5cm.; 7. Women of childbearing age must be confirmed by a pregnancy test that they are not pregnant, and are willing to take effective measures to prevent pregnancy during the test period and within >=12 months after the last dose; Pregnant and lactating females cannot participate; All male subjects used contraception during the trial period and within >=3 months after the last dose; 8. Can provide informed consent, can understand and comply with the requirements of the study.

Exclusion criteria

Exclusion criteria: 1. Have a serious mental illness; 2. Central nervous system involvement; 3. History of other active tumors 4. Pregnant or lactating women 5. Inability to understand or follow the study protocol.

Design outcomes

Primary

MeasureTime frame
2-year central nervous system recurrence rate;

Secondary

MeasureTime frame
Overall response rate;Complete response rate;Partial response rate;Overall survival ;Progression-Free Survival;Safety;

Countries

China

Contacts

Public ContactTong Hongyan

The first affiliated hospital Zhejiang University school of medicine

ruicostas610@sina.com+86 571 8723 5560

Outcome results

None listed

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