A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma (NCT07075328) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma
Japan49 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range20 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prio…
What they're measuring
1
Phase I part: Dose limiting toxicity
Timeframe: Phase I part: 2 weeks
2
Phase II part: Response rate (best overall response)