Autoimmune Cytopenia and BcR Inhibitors

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Autoimmune Cytopenia Associated With Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: ibrutinib ou idelalisib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| active CLL treated with ibrutinib or idelalisib for CAI<br>Patient with CLL Active autoimmune cytopenia Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia. The progressive nature of contemporary CAI LLC is not a criterion of exclusion. | Drug: ibrutinib ou idelalisib<br>* treatment by ibrutinib or idelalisib for autoimmune cytopenia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of B-cell receptor inhibitors on autoimmune cytopenia (AIC) | Regarding autoimmune cytopenias, the responses to treatments were defined as such: Complete answer hemoglobin level> 120 g/l without transfusion AND platelet count> 100 G/l AND reticulocytes <100 G/l AND normal LDH level Partial answer hemoglobin <120 g/l but with a gain of 2 g/l, without transfusion OR hemoglobin> 120 g/l with reticulocytes> 100 G/l and or high LDH OR hemoglobin> 120 g/l with reticulocytes and / or LDH levels not available AND OR platelet count between 50 and 100 G/l | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of B-cell receptor inhibitors on the Chronic lymphocytic leukemia (CLL) | Regarding CLL, the responses were defined according to the IWCLL 2008 criteria. Due to the absence of a medullary assessment biopsy, patients presenting the complete clinical and biological response criteria will be considered in a complete clinical response. | 1 year | 
| Progression Free Survival (PFS) of the autoimmune cytopenia | Progression Free Survival (PFS) of the autoimmune cytopenia | 1 year | 
| PFS of the Chronic lymphocytic leukemia | PFS of the Chronic lymphocytic leukemia | 1 year | 
| Event Free Survival (EFS) | Event Free Survival (EFS) | 1 year | 
| Time to next treatment (TTNT) | Time to next treatment (TTNT) | 1 year | 
| Toxicity profile | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 year | 
| Overall survival | Overall survival | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Lymphocytic Leukemia, Autoimmune Cytopenias, BCR inhibitors