Adult T-Cell Leukemia/Lymphoma (ATLL)
Conditions
Brief summary
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.
Detailed 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.
Interventions
OTHERDrug:5-ALA, Device:Photodynamic system
\[Phase I part\] 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.
Sponsors
Otsuka Medical Devices Co., Ltd. Japan
JIMRO Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I part: Dose limiting toxicity | Phase I part: 2 weeks |
| Phase II part: Response rate (best overall response) | Phase II part: 24 weeks |
Countries
Japan
Contacts
CONTACTKentaro Ishinabe
Outcome results
None listed