A Phase II Study of YHI-1702

JRCT ID: jRCT2071210133

Registered date:14/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult T-cell leukemia/lymphoma
• Date of first enrollment: 01/04/2022
• Target sample size: 21
• Study type: Interventional
• Intervention(s): Patients will receive duvelisib administered orally BID in a 28-day treatment cycle.

Outcome(s)

• Primary Outcome: Overall response rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hiroki Kageyama