Clinical trial · Interventional
A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145)
A Long-term, Continued Treatment and Follow-up Study in Subjects With Hematologic Malignancies Treated With Duvelisib (IPI-145)
NCT02711852CI-TRIAL-00069494completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duvelisib | Drug | Duvelisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Duvelisib
- description
- Participants received the same dose from their previous duvelisib study. All doses were taken twice daily. Two dose reductions were allowed per participant, but doses were not less than 10 milligrams (mg). Participants received duvelisib until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Duvelisib
Primary outcomes (1)
- measure
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
- timeFrame
- Up to 45 months
- description
- A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Secondary outcomes (2)
- measure
- Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.