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

A Phase Ib Study of YHI-1702 (duvelisib) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224791
Enrollment
10
Registered
2019-07-18
Start date
2019-10-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lymphocytic leukemia/small lymphocytic lymphoma

Interventions

investigational material(s) Generic name etc : YHI-1702 INN of investigational material : Duvelisib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Sponsors

Yakult Honsha Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
efficacy ORR

Secondary

MeasureTime frame
safety efficacy PFS OS

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026