Adult T-cell leukemia/lymphoma
Conditions
Sponsors
Hiroki Kageyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Hematocytologically or histopathologically proven ATL with positivity of anti-HTLV-1 antibody 2) Diagnosed as aggressive ATL (acute type, lymphoma type, or chronic type with unfavorable factor ATL) 3) Receiving at least one prior systemic therapy including mogamulizumab-containing regimen or, if mogamulizumab-intolerant or contraindication, one or more regimens of systemic therapies excluding mogamulizumab 4) Must have at least one measurable lesion, or evaluable lesion in either of peripheral blood or skin based on the response criteria defined in this study 5) ECOG PS of 0 to 1 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Received prior allogeneic transplant, or prior autologous transplant within 12 weeks (84 days) prior to initiation of study treatment 2) Received prior treatment with PI3K inhibitors 3) Ongoing treatment for systemic bacterial, fungal, or viral infection 4) Administration of medications or foods that are strong inhibitors or inducers of CYP3A within 14 days of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Contacts
Public ContactClinical Development
Yakult Honsha Co., Ltd.
Outcome results
None listed