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

April 9, 2024 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who discontinued ibrutinib
CLL patients enrolled in the front-line GIMEMA LLC1114 study twho discontinued ibrutinib due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up.
Other: Observation
Patients will be observed after ibrutinib discontinuation and data on ibrutinib discontinuation, reatreatment and outcome will be collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 and 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Francresca Romana Mauro, University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLL2523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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