Autoimmune Cytopenia Associated With Chronic Lymphocytic Leukemia Clinical Trial
— CABRIOfficial 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)
| Verified date | March 2018 |
| Source | Institut Paoli-Calmettes |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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)
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | July 2018 |
| Est. primary completion date | July 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Paoli Calmettes | Marseille | Bouches Du Rhone |
| Lead Sponsor | Collaborator |
|---|---|
| Institut Paoli-Calmettes | CHU de Reims |
France,
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* Note: There are 16 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Progression Free Survival (PFS) of the autoimmune cytopenia | Progression Free Survival (PFS) of the autoimmune cytopenia | 1 year | |
| Secondary | PFS of the Chronic lymphocytic leukemia | PFS of the Chronic lymphocytic leukemia | 1 year | |
| Secondary | Event Free Survival (EFS) | Event Free Survival (EFS) | 1 year | |
| Secondary | Time to next treatment (TTNT) | Time to next treatment (TTNT) | 1 year | |
| Secondary | Toxicity profile | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 year | |
| Secondary | Overall survival | Overall survival | 1 year |