A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

February 28, 2028

Study Completion Date

August 31, 2028

Conditions
Adult T-Cell Leukemia/Lymphoma (ATLL)
Interventions
OTHER

Drug:5-ALA, Device:Photodynamic system

"\[Phase I part\] Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive Photodynamic system once.~Dosage of 5-ALA: 10 mg/kg (1st cohort), 20 mg/kg (2nd cohort), 40 mg/kg (3rd cohort), 60 mg/kg (4th cohort) \[Phase II part\] Patients will receive 5-ALA and Photodynamic system once a week for 6 months."

Trial Locations (3)

Unknown

RECRUITING

National Kyushu Cancer Center, Fukuoka

RECRUITING

Imamura general hospital, Kagoshima

RECRUITING

Nagasaki University Hospital, Nagasaki

All Listed Sponsors
collaborator

JIMRO Co., Ltd.

INDUSTRY

lead

Otsuka Medical Devices Co., Ltd. Japan

INDUSTRY