Autoimmune Cytopenia and BcR Inhibitors

• Conditions: Autoimmune Cytopenia Associated With Chronic Lymphocytic Leukemia
• Interventions: Drug: ibrutinib ou idelalisib

• Registration Number: NCT03469895
• Lead Sponsor: Institut Paoli-Calmettes

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

Study Timeline

• Study Start: 2017-07-21
• Status Verified: 2018-03
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-16
• Last Update Submitted: 2018-03-16
• Study First Posted: 2018-03-19
• Last Update Posted: 2018-03-19
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
active CLL treated with ibrutinib or idelalisib for CAI	ibrutinib ou idelalisib	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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)
Time to next treatment (TTNT)	1 year	Time to next treatment (TTNT)
Toxicity profile	1 year	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall survival	1 year	Overall survival

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches Du Rhone, France