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Clinical study of Inotuzumab Ozogamicin in the therapy of relapsed/refractory B-cell lymphoma

Clinical study of Inotuzumab Ozogamicin in the therapy of relapsed/refractory B-cell lymphoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081248
Enrollment
Unknown
Registered
2024-02-27
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Relapsed/refractory B-cell lymphoma

Interventions

Treatment of relapsed/refractory B-cell lymphoma group with Ogatizumab:Inotuzumab Ozogamicin therapy

Sponsors

Tianjin First Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Patients with R/R aggressive B-cell lymphoma undergoing third-line or above treatment or their legal guardians sign informed consent for treatment. 2) Male or female patients aged 18-80 years old (including 18 and 80 years old). 3) R/R aggressive B-cell lymphoma was confirmed by pathology, histology and flow cytometry. (1) Liver function: ALT/AST<3 times the upper limit of normal (ULN) and bilirubin =34.2µmol/L; (2) Renal function: creatinine <100µmol/L; (3) Lung function: indoor oxygen saturation =95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) =40%. 5) The patient's peripheral venous blood flow is smooth, which can meet the needs of intravenous infusion. 6) The patient's Karnofsky score was =60.

Exclusion criteria

Exclusion criteria: 1) Women who are pregnant (urine/blood pregnancy test positive) or breastfeeding. 2) Have an infectious disease that cannot be controlled. 3) HIV-infected patients. 4) Pathologically diagnosed with primary tumors other than R/R aggressive B-cell lymphoma. 5) Suffering from serious autoimmune diseases or immunodeficiency diseases. 6) According to the investigators' judgment, the patient has other inappropriate conditions.

Design outcomes

Primary

MeasureTime frame
PFS of 6 month and 12 month;

Secondary

MeasureTime frame
objective remission rate;complete remission rate;duration of response of one year;overall survival of one year;event free survival of one year;

Countries

China

Contacts

Public ContactDeng Qi

Tianjin First Central Hospital

kachydeng@126.com+86 136 1205 5872

Outcome results

None listed

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