NCT06084923

Outcomes of Unfit Patients With CLL Included in the GIMEMA LLC1114 Trial Who Discontinued Ibrutinib Due to Reasons Other Than Disease Progression

Outcomes of Unfit Patients With Chronic Lymphocytic Leukemia (CLL) Included in the Front-line GIMEMA LLC1114 Trial Who Discontinued Ibrutinib Due to Reasons Other Than Disease Progression: a Multicenter Retrospective/ Prospective Observational Study.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 73 (estimated)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to assess in the cohort of CLL patients enrolled in the front-line GIMEMA LLC1114 study who discontinued ibrutinib the time to subsequent treatment. The main question it aims to answer is: • The 12 and 24-month TTNT measured from the time of ibrutinib discontinuation due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up. Participants will be observed for the duration of the study.

Detailed description

This is an observational, multicenter, retrospective and prospective study aimed at analyzing in the cohort of CLL patients enrolled in the front-line GIMEMA LLC1114 study the time to next treatment in patients who discontinued ibrutinib due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
OTHER	Observation	Patients will be observed after ibrutinib discontinuation and data on ibrutinib discontinuation, reatreatment and outcome will be collected

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-10-16
• Last updated: 2024-04-10