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

SecuraBio19 enrolled

Overview

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 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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematologic Malignancy

Interventions

DuvelisibDRUG

Administered as oral capsules

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Unnamed facility

Denver, Colorado, United States

Unnamed facility

Sarasota, Florida, United States

Unnamed facility

Nashville, Tennessee, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 45 months

Secondary Outcomes

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).

Time frame: 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.

Time frame: Up to 45 months

Data from ClinicalTrials.gov

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