Clinical trial NCT02711852: A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145)
Official title: A Long-term, Continued Treatment and Follow-up Study in Subjects With Hematologic Malignancies Treated With Duvelisib (IPI-145)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematologic Malignancy
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2016-03-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 45 months
Secondary outcomes:
measure: Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator
timeFrame: Up to 45 months
measure: Overall Survival (OS)
timeFrame: Up to 45 months
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
city: Sarasota
country: United States
state: Florida
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria di Terni/SC Oncoematologia
state: Umbria
Study officials:
References: