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New treatment option for Adult T-Cell Leukemia/Lymphoma (ATLL)
Official title A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma
ClinicalTrials.gov ID: NCT07075328
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 85
You may be able to join if
- Hematocytologically or pathohistologically proven adult T-cell leukemia/lymphoma with positivity of anti-HTLV-1 antibody (Aggressive subtypes: acute...
- 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
You likely can't join if
- Body Weight \< 35kg
- Hemoglobin \< 10g/dL
- Splenomegaly
- people 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
See the full eligibility 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
- Body Weight \< 35kg
- Hemoglobin \< 10g/dL
- Splenomegaly
- people 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: people who registrated in phase I part of this trial
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Fukuoka, Japan
- Sapporo, Hokkaido, Japan
- Kagoshima, Kagoshima-ken, Japan
- Miyazaki, Miyazaki, Japan
- Nagasaki, Nagasaki, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Fukuoka, Japan; Sapporo, Hokkaido, Japan; Kagoshima, Kagoshima-ken, Japan; Miyazaki, Miyazaki, Japan; Nagasaki, Nagasaki, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.