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

RecruitingPhase 1, Phase 2Ages 20 Years - 85 YearsAllOtsuka Medical Devices Co., Ltd. Japan
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 * Relapsed or recurrent ATL have history of treatment with mogamulizumab * At least one regimen of chemotherapy in case of intolerance/contraindication for mogamulizumab * Relapsed or recurrent ATL judged inadequate of treatment with mogamulizumab by investigators * Relapsed or recurrent ATL after allogeneic hematopoietic stem cell transplantation * Having peripheral blood lesion * ECOG performance status: 0-2 * T-Bil: =\< ULNx2, AST and ALT: =\< ULNx2.5 * Expected more than 3 months of survival Exclusion Criteria: * Body Weight \< 35kg * Hemoglobin \< 10g/dL * Splenomegaly * Subjects who received an following therapy * Chemotherapy or molecular-targeted agent for ATL : within 28 days prior to registration * Radiotherapy : within 28 days prior to registration * Any investigational drugs or medical devices (unapproved in Japan) : within 28 days prior to registration * Autologous stem cell transplantation : within 84 days prior to registration * Allogenic stem cell transplantation : within 100 days prior to registration * Administrated 5-ALA drug except study drug within 7 days prior to registration * Ate the foods containing 5-ALA or St. John's wort within 7 days prior to registration * Synchronous or metachronous malignancy * Uncontrolled severe complications * Porphyria * Uncontrolled cardiac arrhythmia or Chronic congestive heart failure (NYHA Class III or IV) * Uncontrolled inter-current illness including: heart failure, kidney failure, liver failure, hypertension, diabetes mellitus * Psychological disorder (mental illness, dementia, depression) * HBs-Ag positive or HBc-Ab positive with HBV-DNA positive * HCV-Ab positive * HIV-Ab positive * CNS involvement at screening * QTcF \> 470ms at screening * Uncontrolled intercurrent infection * Pregnant or nursing women * During participated in other clinical trials * Other inadequate conditions determined by investigators * In phase II part: subjects who registrated in phase I part of this trial
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What it tests

  • Drug:5-ALA, Device:Photodynamic system
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Where

5 sites
National Kyushu Cancer Center
Fukuoka, Japan
Sapporo Hokuyu Hospital
Sapporo, Japan
Imamura general hospital
Kagoshima, Japan
University of Miyazaki Hospital
Miyazaki, Japan
Nagasaki University Hospital
Nagasaki, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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