Phase 2
Completed N=19
A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145)
Hematologic Malignancy
Source: ClinicalTrials.gov NCT02711852 ↗
Enrolled (actual)
19
Serious AEs
26.3%
Results posted
Feb 2023
Primary outcomePrimary: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) — 17 Participants
Summary
This was a long-term, continued treatment study that evaluated the long-term safety, clinical activity, and overall survival (OS) of duvelisib in individuals with hematologic malignancies that were previously treated with duvelisib in a previous sponsor-approved study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) |
17 | — |
| SECONDARY Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator |
9; 5; 1; 1 | — |
| SECONDARY Overall Survival (OS) |
14 | — |
Eligibility Criteria
Inclusion Criteria
- Have participated in a previous study of duvelisib, and:
- Be actively receiving duvelisib monotherapy on the previous study (within 14 days of study entry) and demonstrating clinical benefit (complete response [CR]/ partial response [PR]/ stable disease [SD]) of continued use, or
- Be in the survival follow-up phase of a previous duvelisib study
- Have completed the required components of the previous study and be appropriate for enrollment into this long-term continued treatment and follow-up study, as determined by the Sponsor
Exclusion Criteria
- Had any ongoing ≥ Grade 3 adverse event (AE) considered related to duvelisib treatment at screening
- Was pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT02711852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.