This study aims to evaluate the tolerability of OJP-001, a therapeutic system combining photodynamic therapy (PDT) using OMD-001 and extracorporeal circulation therapy using OJE-001 and OJC-001, in patients with adult T-cell leukemia/lymphoma (ATL). The study will also investigate the recommended dose and pharmacokinetics of OMD-001, as well as the efficacy and safety of OJP-001.
\[Phase I part\] Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive OJP-001 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 OJP-001 once a week for 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
\[Phase I part\] 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.
Sapporo Hokuyu Hospital
Sapporo, Hokkaido, Japan
RECRUITINGImamura general hospital
Kagoshima, Kagoshima-ken, Japan
RECRUITINGNational Kyushu Cancer Center
Fukuoka, Japan
RECRUITINGPhase I part: Dose limiting toxicity
Time frame: Phase I part: 2 weeks
Phase II part: Response rate (best overall response)
Time frame: Phase II part: 24 weeks
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Nagasaki University Hospital
Nagasaki, Japan
RECRUITING