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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03545035

Acronym

LLC178

Enrollment

104

Registered

2018-06-04

Start date

2019-02-06

Completion date

2020-10-28

Last updated

2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia, Idelalisib, Rituximab

Brief summary

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.

Detailed description

This cohort study will recruit 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 between 01/07/2014 and 31/05/2017 at European centres adhering to the GIMEMA group and the ERIC group.

Interventions

DRUGidelalisib and rituximab

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 design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/SLL) according to the World Health Organisation (WHO) classification 2008. * Treatment with idelalisib and rituximab started between the date of Country marketing authorization approval of idelalisib (EMA approval 18/09/2014) and 31/05/2017 given at European centres adhering to the GIMEMA group and the ERIC group. * One of the two following conditions must be satisfied: * Previously untreated CLL requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008)\] with deletion 17p13 and/or TP53 mutation. * Relapsed refractory CLL., i.e. patients who received at least one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, or high dose steroids requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008) * Age ≥ 18 years. * Signed written informed consent, if applicable, according to ICH/EU/GCP and national local law.

Exclusion criteria

* Patients with CLL treated with idelalisib within interventional clinical trials or outside the approved indication. * Patients with: * Transformation of CLL to aggressive lymphomas (Richter's Syndrome). * HIV infection. * Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.

Design outcomes

Primary

Measure	Time frame	Description
Number of patients responding to treatment	At 12 months from treatment start	Efficacy profile of idelalisib and rituximab
Number of patients experiencing toxicities	At 12 months from treatment start	Safety profile of idelalisib and rituximab

Secondary

Measure	Time frame	Description
Number of patients alive	At 12 months from treatment start	Overall survival
Number of patients alive without progression of the disease	At 12 months from treatment start	Progression-free-survival
Number of patients achieving response	At 12 months from treatment start	Overall response rate

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026