A follow-up study in patients with hematologic malignancies that are treated with experimental drug duvelisib

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000848-34-IT

Enrollment

Registered

2022-01-20

Start date

2016-09-21

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancies MedDRA version: 21.1 Level: LLT Classification code 10066481 Term: Hematological malignancy System Organ Class: 100000004864

Interventions

Product Name: Duvelisib Product Code: [IPl-145] Pharmaceutical Form: Capsule, hard INN or Proposed INN: Duvellsib CAS Number: 1386861-48-9 Current Sponsor code: IPl-145 Other descriptive name: / Conce

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Subjects actively receiving duvelisib are to be excluded from this study if theyHave any ongoing = Grade 3 AE considered related to duvelisib treatment at screening

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to capture long term safety data in subjects with hematologic malignancies treated with duvelisib.;Secondary Objective: •The long term clinical activity of duvelisib in subjects with hematologic malignancies. •OS of subjects with hematologic malignancies treated with duvelisib.;Primary end point(s): The primary endpoints in this study are adverse events (AEs) and safety laboratory test values.;Timepoint(s) of evaluation of this end point: NA	—

Measure

Time frame

Main Objective: The primary objective of this study is to capture long term safety data in subjects with hematologic malignancies treated with duvelisib.;Secondary Objective: •The long term clinical activity of duvelisib in subjects with hematologic malignancies. •OS of subjects with hematologic malignancies treated with duvelisib.;Primary end point(s): The primary endpoints in this study are adverse events (AEs) and safety laboratory test values.;Timepoint(s) of evaluation of this end point: NA

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: NA;Secondary end point(s): There are no formal secondary endpoints planned for this long term study. Data will be captured to support the clinical endpoints based on the disease response assessment and OS as defined in the subject's previous study.	—

Countries

Italy, Poland, United States

Contacts

Public ContactHagop Youssoufian

Verastem, Inc

hyoussoufian@verastem.com0016178120059

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026