Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study
- Registration Number
- NCT03545035
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
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Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/SLL) according to the World Health Organisation (WHO) classification 2008.
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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.
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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)
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Age ≥ 18 years.
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Signed written informed consent, if applicable, according to ICH/EU/GCP and national local law.
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Patients with CLL treated with idelalisib within interventional clinical trials or outside the approved indication.
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Patients with:
- Transformation of CLL to aggressive lymphomas (Richter's Syndrome).
- HIV infection.
- Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group idelalisib and rituximab All patients being observed during the study duration.
- Primary Outcome Measures
Name Time Method Number of patients experiencing toxicities At 12 months from treatment start Safety profile of idelalisib and rituximab
Number of patients responding to treatment At 12 months from treatment start Efficacy profile of idelalisib and rituximab
- Secondary Outcome Measures
Name Time Method Number of patients achieving response At 12 months from treatment start Overall response rate
Number of patients alive without progression of the disease At 12 months from treatment start Progression-free-survival
Number of patients alive At 12 months from treatment start Overall survival
Trial Locations
- Locations (38)
AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione
🇮🇹Cona, Ferrara, Italy
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
🇮🇹Alessandria, Italy
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica
🇮🇹Ancona, Italy
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
🇮🇹Ascoli Piceno, Italy
Asl Di Asti, Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia
🇮🇹Asti, Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
🇮🇹Brescia, Italy
AO Brotzu, PO A.Businco - SC Ematologia e CTMO
🇮🇹Cagliari, Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
🇮🇹Catania, Italy
Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia
🇮🇹Catanzaro, Italy
Aou Careggi - Firenze - Sod Ematologia
🇮🇹Firenze, Italy
Scroll for more (28 remaining)AOU Arcispedale S.Anna - UOC Ematologia e fisiopatologia della coagulazione🇮🇹Cona, Ferrara, Italy