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Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study (LLC178)

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ClinicalTrials.gov Identifier: NCT03545035
Recruitment Status : Not yet recruiting
First Posted : June 4, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
ERIC Group
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia Drug: idelalisib and rituximab

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.

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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL) Treated With Idelalisib and Rituximab in the Clinical Practice: a GIMEMA-ERIC Study
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
Study group
All patients being observed during the study duration.
Drug: idelalisib 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




Primary Outcome Measures :
  1. Number of patients responding to treatment [ Time Frame: At 12 months from treatment start ]
    Efficacy profile of idelalisib and rituximab

  2. Number of patients experiencing toxicities [ Time Frame: At 12 months from treatment start ]
    Safety profile of idelalisib and rituximab


Secondary Outcome Measures :
  1. Number of patients alive [ Time Frame: At 12 months from treatment start ]
    Overall survival

  2. Number of patients alive without progression of the disease [ Time Frame: At 12 months from treatment start ]
    Progression-free-survival

  3. Number of patients achieving response [ Time Frame: At 12 months from treatment start ]
    Overall response rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545035


Contacts
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Contact: Paola Fazi +39 06 70390528 p.fazi@gimema.it
Contact: Enrico Crea +39 06 70390514 e.crea@gimema.it

Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
ERIC Group
Investigators
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Study Chair: Antonio Cuneo Ematologia; Azienda Ospedaliera di Ferrara
Study Director: Gian Matteo Rigolin Ematologia; Azienda Ospedaliera di Ferrara

Additional Information:
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT03545035     History of Changes
Other Study ID Numbers: LLC1718
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Chronic Lymphocytic Leukemia
Idelalisib
Rituximab

Additional relevant MeSH terms:
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Idelalisib
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action