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Observational Study on Chronic Myeloid Leukemia Patients in Any Phase Treated With Ponatinib (Iclusig®) at Any Dose (Ponderosa)

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ClinicalTrials.gov Identifier: NCT03933852
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Andreas Hochhaus, University of Jena

Study Description
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Brief Summary:
Additional information is needed to characterize the safety profile of ponatinib as it is used in routine clinical practice in Europe. This observational cohort study will provide a real-life picture of ponatinib use in clinical practice and additional quantification and characterization of adverse events (AEs) and their outcomes in patients with Chronic Myeloid Leukemia in any phase treated with ponatinib.

Condition or disease
Chronic Myeloid Leukemia, Chronic Phase

Detailed Description:

This study is a multicentre, long-term, prospective and retrospective, observational cohort study of patients who are treated with ponatinib. The study is non-interventional; all Treatment decisions are made at the discretion of the patient's healthcare provider (HCP) and are not mandated by the study design or protocol.

A heterogeneous sample of oncology practice sites in Germany (both Hospitals and Field based Haematologists) treating adult patients with Chronic Myeloid Leukemia in any phase using ponatinib will be selected for participation in the study. Eligible, consenting patients initiating treatment with ponatinib will be enrolled into the prospective part of the study. Eligible consenting patients with Chronic Myeloid Leukemia in any Phase that have initiated ponatinib outside clinical trial after its approval in Germany will be enrolled in the retrospective part of the study.

Approximately 100 patients will be enrolled from approximately 50 sites. The patient enrolment period is estimated to be approximately two years. Patients who experience an Adverse Event (AE) during treatment or within the 30 days post discontinuation will be followed for 12 months to determine the consequences of the Adverse Event. Data on patient's history, patient's data at baseline, ponatinib treatment, Adverse Events, all medications received, and efficacy measures will be collected during the study in conjunction with routine care visits, anticipated to be approximately every 3 months.

Information on any new therapies, including treatment for Chronic Myeloid Leukemia and other medications will be collected during follow-up.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational Study on Chronic Myeloid Leukemia Patients in Any Phase Treated With Ponatinib (Iclusig®) at Any Dose
Actual Study Start Date : July 8, 2015
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Change in Cytogenetic response [ Time Frame: through study completion, an average of 3 years ]
    Achievement of cytogenetic Response (percentage of Ph+ metaphases)

  2. Molecular response [ Time Frame: through study completion, an average of 3 year ]
    BCR-ABL in % (lower is better)


Eligibility Criteria
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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
The study will include patients with Chronic Myeloid Leukemia in any phase that are initiating or have initiated treatment with ponatinib and who meet the enrolment criteria and provide informed consent. A group of patients, for whom the decision of starting ponatinib has already been made, but in whom ponatinib has not yet been started, will be identified prospectively and invited to enrol into the study. The study enrolment date is the date the informed consent is signed. An additional group of patients who have received or are receiving ponatinib treatment outside clinical trials will be invited to join the retrospective part of the study.
Criteria

Inclusion Criteria:

  • Adult patients (age ≥18 years) with Chronic Myeloid Leukemia in any phase who are initiating ponatinib monotherapy, or for whom ponatinib monotherapy was initiated after ponatinib approval in Germany. [The decision to prescribe ponatinib must have been made prior to enrolment in the study. Patients enrolled in the retrospective part of the study may or may not be still on ponatinib treatment at the time informed consent is given. These retrospective patients should have started Treatment after 02.02.2015.].
  • 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.
  • Patients with a minimum life expectancy of 3 months

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 who are pregnant and/or breastfeeding
Contacts and Locations
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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): NCT03933852


Contacts
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Contact: Andreas Hochhaus, Prof. Dr. +49 36419396670 ponderosa@med.uni-jena.de

Locations
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Germany
University Hospital Jena Recruiting
Jena, Germany, 07747
Contact: Andreas Hochhaus, Prof. Dr.         
Sponsors and Collaborators
University of Jena
Investigators
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Principal Investigator: Andreas Hochhaus University Hospital Jena
More Information
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Responsible Party: Prof. Dr. med. Andreas Hochhaus, Director Clinic of Internal Medicine II, University of Jena
ClinicalTrials.gov Identifier: NCT03933852    
Other Study ID Numbers: Ponderosa
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
 Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases