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Outcomes of Unfit Patients With CLL Included in the GIMEMA LLC1114 Trial Who Discontinued Ibrutinib Due to Reasons Other Than Disease Progression - Trial NCT06084923

Access comprehensive clinical trial information for NCT06084923 through Pure Global AI's free database. This phase not specified trial is sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto and is currently Not yet recruiting. The study focuses on Chronic Lymphocytic Leukemia. Target enrollment is 73 participants.

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NCT06084923
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Trial Details
ClinicalTrials.gov โ€ข NCT06084923
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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.

Study Focus

Observation

Observational

other

Sponsor & Location

Gruppo Italiano Malattie EMatologiche dell'Adulto

Timeline & Enrollment

N/A

Dec 01, 2023

Dec 01, 2025

73 participants

Primary Outcome

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.

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:
 
 โ€ข 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.

ICD-10 Classifications

Chronic lymphocytic leukaemia of B-cell type
Chronic myelomonocytic leukaemia
Acute myelomonocytic leukaemia
Lymphoid leukaemia
Chronic leukaemia of unspecified cell type

Data Source

ClinicalTrials.gov

NCT06084923

Non-Device Trial