A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma
Plain-language summary
This Phase 1, Phase 2 trial is testing Drug:5-ALA and Device:Photodynamic system for people whose adult T-cell leukemia/lymphoma has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.
Who can join (key eligibility)
- Age 20 Years to 85 Years years
- Lymphoma came back or did not respond to prior treatment
- Must be well enough for treatment (adequate performance status)
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
Drug:5-ALA, Device:Photodynamic system (OTHER): \[Phase I part\] 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.
- Drugs / treatments
- Drug:5-ALA, Device:Photodynamic system
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details