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Trial Title:
Outcomes of Unfit Patients With CLL Included in the GIMEMA LLC1114 Trial Who Discontinued Ibrutinib Due to Reasons Other Than Disease Progression
NCT ID:
NCT06084923
Condition:
Chronic Lymphocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Disease Progression
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Observation
Description:
Patients will be observed after ibrutinib discontinuation and data on ibrutinib
discontinuation, reatreatment and outcome will be collected
Arm group label:
Patients who discontinued ibrutinib
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.
Criteria for eligibility:
Study pop:
CLL patients enrolled in the front-line GIMEMA LLC1114 study who discontinued ibrutinib
due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost
to the follow-up.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
May 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Agency class:
Other
Source:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06084923
