Overview
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.
Description
[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.
Eligibility
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