A Phase II Study of YHI-1702

JRCT ID: jRCT2031210529

Registered date:28/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Follicular lymphoma
• Date of first enrollment: 26/05/2022
• Target sample size: 36
• 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) 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

Exclude criteria

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

Related Information

• Primary Sponsor: Suzuki Kenta