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

Recruiting Phase 1 Phase 2 Interventional Study
Adult T-Cell Leukemia/Lymphoma (ATLL)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
20 – 85
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
49 (estimated)
Sponsor
Otsuka Medical Devices Co., Ltd. Japan · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Hematocytologically or pathohistologically proven adult T-cell leukemia/lymphoma with positivity of anti-HTLV-1 antibody (Aggressive subtypes: acute, lymphoma type, or chronic type with unfavorable factor) * Age: 20-85 * Meeting the any following criteria for screening * Re…
Contacts

Kentaro Ishinabe

+81363617459

OtsukaRegistry-CT@otsuka.jp

CONTACT