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An open single arm clinical study of combination of anti-PD-1 monoclonal antibody and R-CHOP for de novo CD5+ diffuse large B-cell lymphoma

An open single arm clinical study of combination of anti-PD-1 monoclonal antibody and R-CHOP for de novo CD5+ diffuse large B-cell lymphoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072920
Enrollment
Unknown
Registered
2023-06-28
Start date
2021-07-21
Completion date
Unknown
Last updated
2023-07-02

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

experimental group:anti-PD-1 monoclonal antibody and R-CHOP

Sponsors

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed with CD5+ diffuse large B cell lymphoma, previously untreated. 2. Age =18. 3. ECOG: 0-2 points. 4. Measurable lesions on CT scan: at least 1 lesion/lymph node with long axis > 1.5cm. 5. No prior chemotherapy, radiation or antibody therapy (surgery and glucocorticoid can be included). 6. Good organ function (creatinine =1.5mg/ dL, total bilirubin =2.0 mg/ dL, transaminase level less than twice the normal upper limit, left ventricular ejection fraction =50%). 7. No other serious underlying diseases.

Exclusion criteria

Exclusion criteria: 1. Patients with primary or secondary central nervous system lymphoma. 2. Patients receiving glucocorticoid therapy. 3. Patients who cannot aovid pregnancy during treatment. 4. Patients who cannot comply with the requirements of research treatment and monitoring. 5. Patients known to be allergic to any of the drugs in the treatment regimen. 6. Vulnerable groups: including critical patients, pregnant women, people with cognitive impairment, people with mental illness, juveniles, etc. 7. Other patients who were not eligible for inclusion by investigators evaluation.

Design outcomes

Primary

MeasureTime frame
overall response rate;

Secondary

MeasureTime frame
progression-free survival, overall survival, CNS relapse rate;Safety;The relationship between clinicopathologic, cytogenetic and molecular biological characteristics and treatment efficacy;

Countries

China

Contacts

Public ContactJin Zhang

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

Jeanzhang@zju.edu.cn+86 135 8870 6767

Outcome results

None listed

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