Phase III Study of OJP-001 Combined Therapy for Adults Aged 20 to 85 With Recurrent or Relapsed Adult T-cell LeukemiaLymphoma and Peripheral Blood Involvement

What this Trial Is About

Researchers are evaluating the tolerability of OJP-001, a combined therapeutic system that includes photodynamic therapy with OMD-001 and extracorporeal circulation therapies OJE-001 and OJC-001, in patients with adult T-cell leukemialymphoma ATL. The study also aims to find the recommended dose and study the way OMD-001 moves through the body, along with assessing the safety and effectiveness of OJP-001. This is a Phase III clinical trial sponsored by Otsuka Medical Devices Co., Ltd. Japan. In the Phase I part, patients receive a single oral dose of 5-ALA followed by one administration of OJP-001. The 5-ALA dose is increased across four groups from 10 mgkg up to 60 mgkg. In the Phase II part, patients receive both 5-ALA and OJP-001 once a week for six months. The treatment involves the use of a photodynamic system combined with 5-ALA, administered according to the defined dosing schedules. Participants will undergo safety and response evaluations during the first two weeks for Phase I and over 24 weeks for Phase II. The main outcomes measured include dose-limiting toxicities in Phase I and best overall response in Phase II. The study involves monitoring blood levels, physical status, and other health markers to assess treatment effects and safety. Total participation may extend up to six months during the Phase II treatment period.

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