A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145)

Study Overview
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Brief Summary
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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.

Detailed Description
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Study IPI-145-23 was an international, multicenter, open-label, single-arm, Phase 2 study designed to evaluate the long-term safety, clinical activity, and overall survival data of duvelisib in individuals with hematologic malignancies. Only individuals who have participated in a previous duvelisib study that were approved by the sponsor were allowed to enroll in the study. Participants in active treatment and participants in survival follow-up were allowed to rollover to this study. For participants on active treatment, participants continued the same dose from their previous duvelisib study administered twice daily for 28-day continuous cycles until disease progression or unacceptable toxicity and then followed in a survival follow-up period. For participants in survival follow-up, participants continued to be followed-up for survival in this study for the duration as outlined in their previous duvelisib study.

Official Title
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A Long-term, Continued Treatment and Follow-up Study in Subjects With Hematologic Malignancies Treated With Duvelisib (IPI-145)

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Drug: Duvelisib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duvelisib<br>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. | Drug: Duvelisib<br>* Administered as oral capsules<br>* Other names: COPIKTRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Up to 45 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator | There were no formal secondary endpoints planned and captured data was based on disease response assessment and overall survival (OS) as defined in the participant's previous study. BOR was defined as the best time point response that a participant achieves during the study, with the response ranked according to the following order (from best to worst): complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR), stable disease (SD). | Up to 45 months | 
| Overall Survival (OS) | No formal secondary endpoints were planned for this study. OS was monitored in participants who continued to receive duvelisib treatment and/or in the long-term survival follow-up period in a previous duvelisib study and the number of participants alive at end of study were reported. Participants being followed for OS were contacted by the study site approximately every 6 months to collect survival status and data pertaining to any other alternative antineoplastic therapy. | Up to 45 months |