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NCT06084923 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06084923
Other study ID # CLL2523
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date May 2026

Study information
Verified date April 2024
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone 0670390528
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 73
Est. completion date May 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients treated with ibrutinib included in the LLC1114 GIMEMA study who have discontinued ibrutinib after completing 78-months of treatment per protocol OR patients treated with ibrutinib included in the LLC1114 GIMEMA study who were treated for at least 12 months before discontinuing ibrutinib due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up and had achieved a response (CR or PR/PR-L) lasting at least 6 months before discontinuing ibrutinib - Informed consent, if applicable. Exclusion Criteria: - Patients with concomitant conditions that may interfere with an appropriate assessment of the TTNT in the physician opinion.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Patients will be observed after ibrutinib discontinuation and data on ibrutinib discontinuation, reatreatment and outcome will be collected

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Outcome
Type Measure Description Time frame Safety issue
Primary The 12 and 24-month Time To Next Treatment (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. The 12 and 24-month time to the next treatment (TTNT) will be calculated in terms of the proportion of patients who requiring new treatment at 12 and 24 months. 12 and 24 months
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