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A non-interference clinical study to evaluate the treatment of adult large B-cell lymphoma (r/r LBCL) with Axicabtagene Ciloleucel Injection that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

A non-interference clinical study to evaluate the treatment of adult large B-cell lymphoma (r/r LBCL) with Axicabtagene Ciloleucel Injection that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086700
Enrollment
Unknown
Registered
2024-07-09
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

large B cell lymphoma

Interventions

Single arm:None

Sponsors

Ruijin Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Participate in the trial conducted at the Fosun Kite commercial authorization investigational sites in China, receiving Fosun Kite's immunocellular therapy product——Axicabtagene Ciloleucel Injection, for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. 2.Histologically proven large B-cell lymphoma including the following types DLBCL not otherwise specified (ABC/GCB) Primary cutaneous DLBCL, leg type Epstein-Barr virus (EBV) + DLBCL Epstein-Barr virus (EBV) + mucocutaneous ulcer DLBCL associated with chronic inflammation T-cell/histiocyte rich large B-cell lymphoma DLBCL arising from FL This study does not include primary central nervous system lymphoma (PCNSL). 3. All patients participating in this study must sign an informed consent form. For patients who do not have full capacity for civil conduct, their guardians must sign and date the informed consent form after obtaining informed consent.

Exclusion criteria

Exclusion criteria: 1. The patients relapses after second-line or above treatment. 2. The patients with newly treated large B-cell lymphoma.

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS);—

Secondary

MeasureTime frame
best Objective Response Rate;Complete Response (CR) Rate;Partial Response (PR) Rate;Duration of Response (DOR);Progression-free Survival (PFS);To evaluate the safety indicators of Axicabtagene Ciloleucel in the treatment of relapsed/refractory LBCL, including the incidence of various adverse events and serious adverse events, and abnormal laboratory examinations related to safety.;—

Countries

China

Contacts

Public ContactWeili Zhao

Ruijin Hospital, School of Medicine, Shanghai Jiaotong University

zhao.weili@yahoo.com+86 21 6437 0045

Outcome results

None listed

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