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A Study to Evaluate Effectiveness and Safety of Ponatinib in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"

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ClinicalTrials.gov Identifier: NCT03515785
Recruitment Status : Withdrawn (Revisiting the availability of patients with Ph+ ALL that would meet the in-/exclusion criteria of the study led to the decision not to move forward.)
First Posted : May 4, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences International Sàrl )

Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of ponatinib (Iclusig®) in patients with BCR-ABL positive acute lymphoblastic leukemia (ALL) in standard clinical practice in Europe.

Condition or disease
BCR-ABL Positive Acute Lymphoblastic Leukemia

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: A Postmarketing Observational Cohort Study to Evaluate Effectiveness and Safety of Ponatinib (Iclusig®) in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021


Group/Cohort
Ph+ ALL Patients
Patients with Ph+ ALL being treated with Iclusig®.



Primary Outcome Measures :
  1. Complete hematological remission (CR) rate [ Time Frame: 6 months ]
    CR defined as leukemic cells not detectable by light microscopy in bone marrow (BM), peripheral blood (PB), or cerebrospinal fluid (CSF) (BM < 5% blasts).


Secondary Outcome Measures :
  1. CR rate [ Time Frame: 1, 3, 9, and 12 months ]
    CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM < 5% blasts).

  2. CR rate [ Time Frame: 1, 3, 6, 9, and 12 months ]
    CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM < 5% blasts).

  3. Time to CR [ Time Frame: Up to 12 months ]
    Defined as time from enrollment to first CR.

  4. Minimal residual disease (MRD) level [ Time Frame: 3, 6, 9, and 12 months ]
    Minimal residual disease level.

  5. Best MRD (MolR) level rate [ Time Frame: 12 months ]
    MolR defined as molecular/MRD response, less than MolCR.

  6. Time to best MRD (MolR) level [ Time Frame: Up to 12 months ]
    MolR defined as molecular/MRD response, less than MolCR.

  7. Duration of molecular response [ Time Frame: Up to 12 months ]
    Measured by MRD log reduction (MolR).

  8. Duration of best molecular response (MolCR) [ Time Frame: Up to 12 months ]
    MolCR defined as complete molecular remission/MRD negativity.

  9. Time to progression [ Time Frame: Up to 12 months ]
    Defined as the time to molecular relapse or hematological relapse.

  10. Time to death [ Time Frame: Up to 12 months ]
    Defined as time from enrollment to death due to any cause.

  11. Prescribed dose [ Time Frame: Up to 12 months ]
    Prescribed dose of Iclusig® in milligrams.

  12. Daily average dose [ Time Frame: Up to 12 months ]
    The average daily dose of Iclusig® in milligrams.

  13. Number of serious adverse events (SAEs) [ Time Frame: 12 months ]
    Defined as an adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is an important medical event.

  14. Number of adverse events of special interest (AESI) [ Time Frame: 12 months ]
    AESI defined as vascular occlusive events, including arterial and venous events, as defined in the protocol.

  15. Amount of hospital days [ Time Frame: 12 months ]
    Defined as overnight stay(s), each night in the hospital will be counted as 1 day.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with Ph+ ALL being treated with Iclusig® in Europe.
Criteria

Inclusion Criteria:

  • Adult patients with BCR-ABL (Ph+) positive ALL who are initiating Iclusig®, or for whom Iclusig® was initiated after January 2015.
  • Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures.

Exclusion Criteria:

  • Patients previously treated with investigational ponatinib.
  • Patients who are pregnant and/or breastfeeding.
  • Concurrent treatment with another tyrosine kinase inhibitor for Ph+ALL.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515785


Locations
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Czechia
Ihbt/Úhkt
Praha, Czechia, 128 00
France
University Hospital Amiens
Amiens, France, 80080
University Hospital Angers
Angers, France, 49100
University Hospital Bordeaux
Bordeaux, France, 33000
University Hospital Grenoble
Grenoble, France, 38700
University Hospital Lyon
Lyon, France, 69361
University Cancer Institute Oncopole
Toulouse, France, 31059
Germany
University Hospital Halle/Saale
Halle/Saale, Germany, 06120
University Hospital Munich
Munich, Germany, 81377
University Hospital Rostock
Rostock, Germany, 18057
Sponsors and Collaborators
Incyte Biosciences International Sàrl
Investigators
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Principal Investigator: Dieter Hoelzer, Prof. Dr. med. Oncologikum Frankfurt

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Responsible Party: Incyte Biosciences International Sàrl
ClinicalTrials.gov Identifier: NCT03515785     History of Changes
Other Study ID Numbers: INCB-DEMA-ALL-401
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation ( Incyte Biosciences International Sàrl ):
acute lymphoblastic leukemia
ponatinib
tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ponatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action