Skip to content

A prospective, multicenter, open, one arm clinical study on the safety and efficacy of IRM-CHOP regimen in the treatment of CD5 positive diffuse large B-cell lymphoma

A prospective, multicenter, open, one arm clinical study on the safety and efficacy of IRM-CHOP regimen in the treatment of CD5 positive diffuse large B-cell lymphoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067056
Enrollment
Unknown
Registered
2022-12-26
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

CD5+DLBCL

Interventions

experimental group:IRM-CHOP regimen

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following criteria to be enrolled: 1. For newly diagnosed CD5+DLBCL confirmed by pathological tissue (except primary mediastinal large B-cell lymphoma, primary central lymphoma, testicular lymphoma and HIV-related lymphoma), the diagnostic criteria refer to WHO 2016 diagnostic criteria. 2. Age =75 years old with ECOG PS=2 points; 3. Life expectancy is more than 6 months; 4.Ann Arbor stage I-IV; Follow-up is available. The patients knew the characteristics of the disease and voluntarily joined the study protocol for treatment and follow-up.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria are not eligible for inclusion in this study: 1. Patients with abnormal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and/or glutamic-pyruvic transaminase, aspartate transaminase, and serum creatinine > 2 normal values, unless abnormal liver and kidney function is identified as associated with lymphoma; 2. Patients with bone marrow failure, specifically defined as absolute neutrophil count (ANC) 1104 copies /ml) and hepatitis C patients; 6. Lymphoma has been shown to involve the central nervous system; 7. Has been diagnosed with or is undergoing treatment for a malignancy other than lymphoma, except for: ? had received treatment for the purpose of cure, and had no malignancies with known active disease for =5 years prior to enrollment; ? Well-treated basal cell carcinoma of the skin with no signs of disease (except melanoma); ? Well-treated carcinoma in situ of the cervix with no signs of disease. 8. Patients with other hematological diseases (such as hemophilia, myelofibrosis, etc.) are considered not suitable for admission; 9. Complicated with severe infection; 10. Received secondary or higher surgery within 3 weeks prior to treatment; 11. Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or the evaluation of the study results; 12. Those who were considered unsuitable for inclusion by the researchers; Known allergy to test drug ingredients.

Design outcomes

Primary

MeasureTime frame
objective response rate;complete remission rate;part remission rate;

Secondary

MeasureTime frame
overall survival;progression-free survival;

Countries

China

Contacts

Public ContactWei Sang

The Affiliated Hospital of Xuzhou Medical University

xyfylbl515@xzhmu.edu.cn13645207648

Outcome results

None listed

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