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Japanese

Mar. 28, 2025

Sept. 25, 2026

jRCT1013240081

Safety and Efficacy of Axicabtagene Ciloleucel in Relapsed/Refractory Large B Cell Lymphoma (Axi-Cel.24)

Axi-Cel.24 (Axi-Cel.24)

Teshima Takanori

Hokkaido University Hospital

Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo, Hokkaido

+81-11-706-7214

teshima@med.hokudai.ac.jp

Goto Hideki

Hokkaido University Hospital

Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo, Hokkaido

+81-11-706-7214

hidekigt0220@gmail.com

Recruiting

Mar. 28, 2025

Dec. 05, 2024

Observational

single arm study

open(masking not used)

uncontrolled control

treatment purpose

(1) 18 years of age or older at the time of enrollment
(2) Patients who meet the indications specified in Guidelines for the Promotion of Optimal Use, axicabtagene ciloleucel (Ref. 1).
(3) Patents who are scheduled to receive axi-cel at the participating medical institutions in this study (prospective observational study)
(4) Patients who have already received axi-cel administration at a medical institution participating in this study* (retrospective observational study)
(5) Patients who have given their free and voluntary consent to participate in this study or patients who do not refuse to participate in the study.

Patients deemed inappropriate as study subjects by the principal investigator in participating medical institution (hereafter referred to as the "site principal investigator"

18age old over
No limit

Both

relapsed/refractory large B-cell lymphoma.

relapsed/refractory large B-cell lymphoma.

Response rate at 6 months after axi-cel administration (overall response, complete response, partial response)

Gilead Sciences (Kite Pharma)
Gilead Sciences (Kite Pharma)
Not applicable
Hokkaido University Certified Review Board
Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo, Hokkaido, Hokkaido

+81-11-706-7934

recjimu@huhp.hokudai.ac.jp
Approval

Oct. 30, 2024

No

none

History of Changes

No Publication date
6 Sept. 25, 2026 (this page) Changes
5 June. 30, 2026 Detail Changes
4 Feb. 12, 2026 Detail Changes
3 Oct. 15, 2025 Detail Changes
2 Oct. 14, 2025 Detail Changes
1 Mar. 28, 2025 Detail