Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study ID
NCT03545035
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • idelalisib and rituximab — DRUG
    patients with treatment-naïve chronic lymphocytic leukemia (CLL) with TP53 disruption (i.e. 17p- or TP53 mutations) or relapsed/refractory CLL who were treated with idelalisib and rituximab

Study Details

The present study aims at obtaining more in-depth information on how patients with chronic lymphocytic leukemia treated with idelalisib and rituximab react to treatment.

Key Dates

Start date
Feb 6, 2019
Status verified
May 2022
Primary completion
Oct 28, 2020
Completion
Oct 28, 2020

Study Design

Enrollment
104 participants (actual)

Arms

  • Arm: Study group
    All patients being observed during the study duration.

Primary Outcome Measure

Number of patients responding to treatment [ Time Frame: At 12 months from treatment start ]

Related Studies