Autoimmune Cytopenia and BcR Inhibitors

Institut Paoli-Calmettes40 enrolled

Overview

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)

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Autoimmune Cytopenia Associated With Chronic Lymphocytic Leukemia

Interventions

ibrutinib ou idelalisibDRUG

treatment by ibrutinib or idelalisib for autoimmune cytopenia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, France

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 1 year

Progression Free Survival (PFS) of the autoimmune cytopenia

Time frame: 1 year

PFS of the Chronic lymphocytic leukemia

Time frame: 1 year

Event Free Survival (EFS)

Time frame: 1 year

Time to next treatment (TTNT)

Time frame: 1 year

Toxicity profile

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.