OJP-001 treatment for adults with adult T‑cell leukemia/lymphoma
A Phase I/II Study of OJP-001 for Recurrent or Relapsed Adult T-cell Leukemia/Lymphoma Patients With Peripheral Blood Tumor.
This study tests whether OJP-001 — a combination of oral 5‑ALA and an extracorporeal photodynamic system — is safe and can help adults with aggressive adult T‑cell leukemia/lymphoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | Otsuka Medical Devices Co., Ltd. Japan Industry-sponsored |
| Drugs / interventions | mogamulizumab, chemotherapy |
| Locations | 5 sites (Fukuoka, Fukuoka and 4 other locations) |
| Trial ID | NCT07075328 on ClinicalTrials.gov |
What this trial studies
This Phase I/II interventional trial uses oral 5‑ALA plus an extracorporeal photodynamic device (OJP-001) to treat patients with aggressive adult T‑cell leukemia/lymphoma (ATLL). Phase I uses a single dose 5‑ALA dose‑escalation (10, 20, 40, 60 mg/kg) with one administration of OJP-001 to determine tolerability, recommended dose, and pharmacokinetics. Phase II gives 5‑ALA and OJP-001 once weekly for six months to collect efficacy and safety data. Key outcomes include safety/tolerability, recommended Phase II dose, pharmacokinetics of OMD‑001, and clinical response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20–85 with aggressive ATLL (acute, lymphoma type, or chronic with unfavorable features) who have peripheral blood involvement and prior therapy history such as mogamulizumab exposure or relapse after transplant, and who meet laboratory and performance status criteria.
Not a fit: Patients with severe cytopenias (hemoglobin <10 g/dL), splenomegaly, low body weight (<35 kg), significant recent chemotherapy within 28 days, or marked liver dysfunction are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option that reduces disease burden and improves outcomes for patients with relapsed or refractory aggressive ATLL.
How similar studies have performed: Extracorporeal photopheresis and other photodynamic approaches have shown activity in some T‑cell disorders, but combining oral 5‑ALA with this specific OJP-001 extracorporeal PDT system for ATLL is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Fukuoka, Fukuoka and 4 other locations
- National Kyushu Cancer Center — Fukuoka, Fukuoka, Japan (Recruiting)
- Sapporo Hokuyu Hospital — Sapporo, Hokkaido, Japan (Recruiting)
- Imamura general hospital — Kagoshima, Kagoshima-ken, Japan (Recruiting)
- University of Miyazaki Hospital — Miyazaki, Miyazaki, Japan (Recruiting)
- Nagasaki University Hospital — Nagasaki, Nagasaki, Japan (Recruiting)
Study contacts
- Study coordinator: Kentaro Ishinabe
- Email: OtsukaRegistry-CT@otsuka.jp
- Phone: +81363617459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.