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

NCT06084923 | Not Yet Recruiting

• 1 other identifier: CLL2523
• Study Type: observational
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Observation OTHER

Patients will be observed after ibrutinib discontinuation and data on ibrutinib discontinuation, reatreatment and outcome will be collected

Patients who discontinued ibrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Patients with concomitant conditions that may interfere with an appropriate assessment of the TTNT in the physician opinion.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Observation

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Francresca Romana Mauro

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

0670390528; p.fazi@gimema.it

Enrico Crea

CONTACT

0670390514; e.crea@gimema.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 16, 2023
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share