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A Phase Ib Study of YHI-1702 in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 1
Completed
Conditions
Chronic lymphocytic leukemia/small lymphocytic lymphoma
Registration Number
JPRN-jRCT2080224791
Lead Sponsor
Yakult Honsha Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
completed
Sex
All
Target Recruitment
10
Inclusion Criteria

Diagnosis of active CLL or SLL
- Disease that has progressed during or relapsed after at least one previous CLL/SLL therapy
- Measurable disease > 1.5 cm
- ECOG PS of 0 or 1
- Presence of adequate organ and bone-marrow functions

Exclusion Criteria

- History of Richter's transformation or prolymphocytic leukemia
- Known central nervous system lymphoma or leukemia
- Prior exposure to a PI3K inhibitor
- Unstable or severe uncontrolled medical condition
- Pregnant or lactating women

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
efficacy<br>ORR
Secondary Outcome Measures
NameTimeMethod
safety<br>efficacy<br>PFS<br>OS
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