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A Phase II Study of YHI-1702 (duvelisib) in Patients with Relapsed or Refractory Adult T-cell Leukemia/Lymphoma

A Phase II Study of YHI-1702

Hiroki Kageyama

Yakult Honsha Co., Ltd.

1-10-30, Kaigan, Minato-ku, Tokyo

clinical_development@yakult.co.jp

Clinical Development

Yakult Honsha Co., Ltd.

1-10-30, Kaigan, Minato-ku, Tokyo

+81-3-6625-8913

clinical_development@yakult.co.jp

Complete

April. 01, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

Adult T-cell leukemia/lymphoma

Patients will receive duvelisib administered orally BID in a 28-day treatment cycle.

Overall response rate

+81-99-275-5553

Mar. 15, 2022

No

none