Adult T-cell leukemia/lymphoma
Conditions
Interventions
[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), 4
Sponsors
Shiobara Noriyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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) 2) Age: 20-85 3) 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 4) Having peripheral blood lesion 5) ECOG performance status: 0-2 6) T-Bil: =< ULNx2, AST and ALT: =< ULNx2.5 7) Expected more than 3 months of survival
Exclusion criteria
Exclusion criteria: 1) Body Weight 470ms at screening 18) Uncontrolled intercurrent infection 19) Pregnant or nursing women 20) During participated in other clinical trials 21) Other inadequate conditions determined by investigators 22) 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 II part: response rate (best overall response) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I part: pharmacokinetics, safety, response in the peripheral blood lesions Phase II: response rate, survival rate, overall survival rate, overall survival, response rate in each lesion, response duration, disease control rate, time to response, progression free survival, response in the peripheral blood lesions | — |
Contacts
Public ContactNoriyuki Shiobara
JIMRO Co., Ltd.
Outcome results
None listed