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)

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Drug: Duvelisib

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Umbria
    • Terni, Umbria, Italy, 05100
      • Azienda Ospedaliera Santa Maria di Terni/SC Oncoematologia
• United States
  • Colorado
    • Denver, Colorado, United States, 80218
  • Florida
    • Sarasota, Florida, United States, 34232
  • Tennessee
    • Nashville, Tennessee, United States, 37203
  • Texas
    • Houston, Texas, United States, 77030
      • UT MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duvelisib; 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; Administered as oral capsules; Other Names: COPIKTRA; IPI-145; VS-0145

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SecuraBio
• Investigators: Study Director: Study Director, MD, SecuraBio

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): May 4, 2020
• Study Completion (Actual): May 4, 2020

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 16, 2016
• First Posted (Estimated): March 17, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: IPI-145-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No