Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gruppo Italiano Malattie EMatologiche dell'Adulto
With
ERIC Group
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study
