Overview

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

Status:
Completed

Trial end date:
2020-05-04

Target enrollment:
0

Participant gender:
All

Summary

This long-term, continued treatment study will evaluate the long-term safety of duvelisib in patients with hematologic malignancies that were previously treated with duvelisib in a previous sponsor-approved study.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Infinity Pharmaceuticals, Inc.
SecuraBio

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:

- Subjects actively receiving duvelisib are to be excluded from this study if they have any
ongoing ≥ Grade 3 AE considered related to duvelisib treatment at screening