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A Phase II Study of YHI-1702 (duvelisib) in Patients with Relapsed or Refractory Follicular Lymphoma

A Phase II Study of YHI-1702

Suzuki Kenta

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

Feb. 01, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Histologically diagnosed as Grade 1, 2 or 3a FL according to WHO classification
2) Relapsed or refractory disease after receiving at least two prior systemic therapies
3) At least one measurable lesion according to the Lugano classification
4) ECOG PS of 0 to 1
5) Written informed consent

1) Clinically or histologically suspected to be transformation from FL to an aggressive lymphoma or diagnosed as Grade 3b FL according to WHO classification
2) History of interstitial pneumonia or severe lung dysfunction
3) Received prior treatment with duvelisib (Patients who were refractory to PI3K inhibitors other than duvelisib or who experienced severe adverse events during treatment with the PI3K inhibitor were also excluded.)
4) Ongoing treatment for systemic bacterial, fungal, or viral infection
5) Administration of medications or foods that are strong inhibitors or inducers of CYP3A within 14 days of enrollment

Both

Follicular lymphoma

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

Overall response rate

+81-263-35-4600

Jan. 24, 2022

No

none