Autoimmune Cytopenia Associated With Chronic Lymphocytic Leukemia
Conditions
Keywords
Chronic Lymphocytic Leukemia, Autoimmune Cytopenias, BCR inhibitors
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
Interventions
DRUGibrutinib ou idelalisib
treatment by ibrutinib or idelalisib for autoimmune cytopenia
Sponsors
CHU de Reims
Institut Paoli-Calmettes
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of B-cell receptor inhibitors on autoimmune cytopenia (AIC) | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) of the autoimmune cytopenia | 1 year | Progression Free Survival (PFS) of the autoimmune cytopenia |
| PFS of the Chronic lymphocytic leukemia | 1 year | PFS of the Chronic lymphocytic leukemia |
| Event Free Survival (EFS) | 1 year | Event Free Survival (EFS) |
| Efficacy of B-cell receptor inhibitors on the Chronic lymphocytic leukemia (CLL) | 1 year | 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. |
| Toxicity profile | 1 year | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| Overall survival | 1 year | Overall survival |
| Time to next treatment (TTNT) | 1 year | Time to next treatment (TTNT) |
Countries
France
Outcome results
None listed