A Phase II Study of YHI-1702
- Conditions
- Follicular lymphoma
- Registration Number
- JPRN-jRCT2031210529
- Lead Sponsor
- Suzuki Kenta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method