Autoimmune Cytopenia and BcR Inhibitors (CABRI)

March 16, 2018 updated by: Institut Paoli-Calmettes

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)

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Institut Paoli Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with CLL and active autoimmune cytopenia treated with ibrutinib or idelalisib for autoimmune cytopenia.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
active CLL treated with ibrutinib or idelalisib for CAI

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
treatment by ibrutinib or idelalisib for autoimmune cytopenia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of B-cell receptor inhibitors on autoimmune cytopenia (AIC)
Time Frame: 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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
Overall survival
1 year
Efficacy of B-cell receptor inhibitors on the Chronic lymphocytic leukemia (CLL)
Time Frame: 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.
1 year
Progression Free Survival (PFS) of the autoimmune cytopenia
Time Frame: 1 year
Progression Free Survival (PFS) of the autoimmune cytopenia
1 year
PFS of the Chronic lymphocytic leukemia
Time Frame: 1 year
PFS of the Chronic lymphocytic leukemia
1 year
Event Free Survival (EFS)
Time Frame: 1 year
Event Free Survival (EFS)
1 year
Time to next treatment (TTNT)
Time Frame: 1 year
Time to next treatment (TTNT)
1 year
Toxicity profile
Time Frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Collaborators

CHU de Reims

Investigators

  • Principal Investigator: Thérèse Aurran-Schleinitz, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 21, 2017

Primary Completion (ANTICIPATED)

July 1, 2018

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (ACTUAL)

March 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CABRI-IPC 2017-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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