Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT03545035
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03545035
Study Brief:
Protocol Section:
NCT03545035