Clinical-biological Characteristics and Outcome of Chronic Lymphocytic Leukemia Under Ibrutinib-named Patient Program

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study ID
NCT02582320
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be observed for at least 12 months from the treatment start.

Study Details

This is a retrospective observational study aimed at describing the characteristics and outcome of CLL patients included in the NPP in Italy in a period of time ranging from the start of the NPP until November, 30th 2014. A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be observed for at least 12 months from the treatment start.

Key Dates

Start date
Mar 31, 2016
Status verified
Sep 2021
Primary completion
Oct 31, 2018
Completion
Oct 3, 2018

Study Design

Enrollment
264 participants (actual)

Arms

  • Arm: Study patients
    Patients with Relapsed or refractory CLL or 17p deleted CLL fulfilling the eligibility criteria required by the Named Patient Program (NPP) who received at least 1 dose of Ibrutinib 420 mg daily before November, 30th 2014.

Primary Outcome Measure

Number of patients who progress [ Time Frame: At 12 months from the start of Ibrutinib ]

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