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 range
20 Years – 85 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)