Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®)

September 26, 2023 updated by: Incyte BioSciences France

Observational Study on CML Patients in Any Phase of the Disease Treated With Ponatinib (Iclusig®): A Multicentre, Ambispective Cohort Study

This is a multicentre ambispective cohort study involving French patients who have started or are receiving for less than 6 months a treatment with ponatinib. This study aims at better qualifying the ponatinib benefit-risk balance in real life and in relation with CML patients' therapeutic history.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

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
      • Amiens Cedex, France, 80054
        • CHU Amiens-Picardie- Site SUD
      • Angers, France, 49100
        • CHU d'Angers
      • Annecy, France, 74370
        • CH Annecy
      • Argenteuil Cedex, France, 95107
        • Centre Hospitalier Argenteuil
      • Avignon, France, 84000
        • Centre hospitalier d'Avignon
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Béziers, France, 34500
        • Ch Beziers
      • Castelnau-Le-Lez, France, 34170
        • Cabinet D'hematologie De La Clinique Du Parc
      • Chalon-sur-Saône, France, 71321
        • CH William Morey
      • Chambéry, France, 73000
        • CH Chambery
      • Clermont-Ferrand Cedex, France, 63003
        • CHU Estaing Clermont Ferrand
      • Dijon, France, 21000
        • CHU Dijon, François Mitterrand
      • Dunkerque, France, 59240
        • Centre Hospitalier de Dunkerque
      • La Roche-sur-Yon, France, 85000
        • Centre Hospitalier Departemental Vendee
      • Le Chesnay, France, 78157
        • CH De Versailles (Andre Mignot)
      • Le Kremlin-Bicêtre, France, 94270
        • Hôpital Bicêtre
      • Libourne, France, 33505
        • CH de Libourne
      • Lille Cedex, France, 59037
        • CHRU de Lille - Hopital Huriez
      • Limoges Cedex, France, 87042
        • CH Limoges
      • Lyon, France, 69373
        • Leon Berard, Lyon
      • Meaux, France, 77100
        • Centre Hospitalier de Meaux
      • Metz, France, 57000
        • Hopitaux Prives Metz Centre De Belle-Isle
      • Metz, France, 57530
        • CH De Metz (Hopital De Mercy - CHR Metz Thionville)
      • Montpellier, France, 34090
        • CHU Montpellier
      • Paris, France, 75013
        • Hopital Salpetriere
      • Paris, France, 75015
        • Hôpital Necker
      • Paris, France, 75013
        • La Pitié Salpêtrière - Paris
      • Perpignan, France, 66000
        • CH St Jean
      • Poitiers, France, 86021
        • CHU De Poitiers
      • Pontoise, France, 95300
        • Hôpital René Dubos
      • Quimper, France, 29107
        • CH de Cornouaille
      • Rennes, France, 35033
        • CHU de Rennes
      • Roubaix, France, 59056
        • Hopital Victor Provo
      • Strasbourg, France, 67000
        • La Clinique Sainte-Anne
      • Strasbourg, France, 67200
        • CHRU Strasbourg
      • Toulouse, France, 31059
        • Institut Universitaire Du Cancer Toulouse - Oncopo
      • Troyes, France, 10000
        • Ch Troyes
      • Vandoeuvre Lès Nancy, France, 54511
        • CHRU de Nancy - Hopitaux de Brabois
      • Vandoeuvre Lès Nancy, France, 54511
        • CHU Sud, St Pierre - La Réunion
    • Reunion
      • Saint-Pierre, Reunion, France, 97410
        • CHU SUD Reunion GHSR

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

70 public and private French investigative centers of hematology will be recruited.

Description

Inclusion Criteria:

  • Presenting a CML in any phase.
  • Having initiated for less than six months a treatment with ponatinib.
  • The ability to understand the requirements of the study and to comply with the study data collection procedures.

Exclusion Criteria:

  • Patients previously treated with investigational ponatinib (within a clinical trial).
  • Patients receiving an investigational agent.
  • Patients who are pregnant and/or breastfeeding.
  • Patients with contraindications for Ponatinib according to Summary of Products Characteristics.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
For participants in chronic myeloid leukemia in accelerated phase (AP-CML) or chronic myeloid leukemia in blast phase (BP-CML): Proportion of participants who achieve a complete hematologic response
Time Frame: from 24-60 months
CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia.
from 24-60 months
For participants in chronic myeloid leukemia in chronic (CP-CML) phase: Proportion of participants who achieve a major molecular response after the initiation of study treatment
Time Frame: from 24-60 months
Chronic myeloid leukemia (CML) response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia (Hochhaus et al Leukemia 2020).
from 24-60 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of participants in CP-CML phase who achieved complete hematologic response
Time Frame: from 24-60 months
CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia.
from 24-60 months
Proportion of participants in AP and BP phases who achieved major (complete + partial) cytogenetic response
Time Frame: from 24-60 months
CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia.
from 24-60 months
Proportion of participants who achieved major molecular response and/or depth molecular response: (MR4 or MR4.5 or MR5)
Time Frame: from 24-60 months
CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia.
from 24-60 months
Duration of response
Time Frame: from 24-60 months
Duration of CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia.
from 24-60 months
Time to progression to AP-CML or BP-CML (for those participants not in AP-CML or BP-CML)
Time Frame: from 24-60 months
Time to progression to AP-CML defined as follows: Blasts in blood or marrow 15%-29%, or blasts plus promyelocytes in blood or marrow > 30%, with blasts < 30%; basophils in blood ≥ 20%; persistent thrombocytopenia (< 100 × 10^9/L) unrelated to therapy; clonal chromosome abnormalities in Ph1 cells (CCA/Ph1), major route, on treatment. Time to progression to BP-CML defined as follows: Blasts in blood or marrow ≥ 30%; extramedullary blast proliferation, apart from spleen.
from 24-60 months
Dose reduction (after response) in each cohort
Time Frame: from 24-60 months
Includes level of response at the time of dose reduction and maintenance of response after dose reduction.
from 24-60 months
Time to response
Time Frame: from 24-60 months
Time to CML response criteria as defined by the European LeukemiaNet Recommendations for Management of Chronic Myeloid Leukemia.
from 24-60 months
Rate of progression to accelerated phase (AP-) or blast phase (BP-) CML
Time Frame: from 24-60 months
Rate of progression to AP- or BP-CML as defined in European LeukemiaNet (ELN) criteria.
from 24-60 months
Progression-free survival (PFS)
Time Frame: from 24-60 months
Survival without any progression to AP or BP according to ELN criteria.
from 24-60 months
Overall survival (OS)
Time Frame: from 24-60 months
Overall survival defined according to ELN criteria.
from 24-60 months
Rate of adverse events
Time Frame: from 24-60 months
Adverse event is any untoward medical occurrence in a patient or clinical study subject administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment.
from 24-60 months
Rate of discontinuation due to adverse events in each dose cohort
Time Frame: from 24-60 months
Adverse event is any untoward medical occurrence in a patient or clinical study subject administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment.
from 24-60 months
Dose reductions (prior to response) in each dose cohort
Time Frame: from 24-60 months
Reduction in the dose of Iclusig.
from 24-60 months
Dose interruptions in each dose cohort
Time Frame: from 24-60 months
Interruption of Iclusig treatment.
from 24-60 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte BioSciences France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali G. Turnan, MD, PhD, Paris Sud University Hospitals-Bicetre

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-A01355-48

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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