Clinical trial NCT03469895: Autoimmune Cytopenia and BcR Inhibitors
Official title: Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated With Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Cytopenia Associated With Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Autoimmune Cytopenias
BCR inhibitors
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: CHU de Reims
First posted: 2018-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CLL and active autoimmune cytopenia treated with ibrutinib or idelalisib for autoimmune cytopenia.

Brief summary: Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated with Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)

Detailed description: The investigators of the study propose a card of data collection, validated by the scientific council of the group FILO.

The data to be collected are entered on an e-CRF made available to the investigators on a secure site.

The main data collected are as follows

* anonymized demographic data
* Clinical and Biological Data of CLL at Diagnosis
* Previous treatments of LLC and CAI
* clinical and laboratory data at the time of initiation of BCRi treatment
* response to treatment with BCRi
* tolerance to BCRi treatment
* Progression under treatment with BCRi
* Recent news

Eligibility criteria: Inclusion Criteria:

* Patient with CLL
* Active autoimmune cytopenia
* Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia.

Exclusion Criteria:

* Other lymphoid hemopathy B
* Absence of documentation of the autoimmunity of cytopenia

Primary outcomes:
measure: Efficacy of B-cell receptor inhibitors on autoimmune cytopenia (AIC)
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy of B-cell receptor inhibitors on the Chronic lymphocytic leukemia (CLL)
timeFrame: 1 year
measure: Progression Free Survival (PFS) of the autoimmune cytopenia
timeFrame: 1 year
measure: PFS of the Chronic lymphocytic leukemia
timeFrame: 1 year
measure: Event Free Survival (EFS)
timeFrame: 1 year
measure: Time to next treatment (TTNT)
timeFrame: 1 year
measure: Toxicity profile
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Thérèse Aurran-Schleinitz
role: PRINCIPAL_INVESTIGATOR
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