Clinical trial NCT03515785: A Study to Evaluate Effectiveness and Safety of Ponatinib in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"
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"
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: BCR-ABL Positive Acute Lymphoblastic Leukemia
Keywords: acute lymphoblastic leukemia
ponatinib
tyrosine kinase inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Ph+ ALL being treated with Iclusig® in Europe.

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.


Eligibility 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.

Primary outcomes:
measure: Complete hematological remission (CR) rate
timeFrame: 6 months
Secondary outcomes:
measure: CR rate
timeFrame: 1, 3, 9, and 12 months
measure: CR rate
timeFrame: 1, 3, 6, 9, and 12 months
measure: Time to CR
timeFrame: Up to 12 months
measure: Minimal residual disease (MRD) level
timeFrame: 3, 6, 9, and 12 months
measure: Best MRD (MolR) level rate
timeFrame: 12 months
measure: Time to best MRD (MolR) level
timeFrame: Up to 12 months
measure: Duration of molecular response
timeFrame: Up to 12 months
measure: Duration of best molecular response (MolCR)
timeFrame: Up to 12 months
measure: Time to progression
timeFrame: Up to 12 months
measure: Time to death
timeFrame: Up to 12 months
measure: Prescribed dose
timeFrame: Up to 12 months
measure: Daily average dose
timeFrame: Up to 12 months
measure: Number of serious adverse events (SAEs)
timeFrame: 12 months
measure: Number of adverse events of special interest (AESI)
timeFrame: 12 months
measure: Amount of hospital days
timeFrame: 12 months
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Ihbt/Úhkt
city: Amiens
country: France
facility: University Hospital Amiens
city: Angers
country: France
facility: University Hospital Angers
city: Bordeaux
country: France
facility: University Hospital Bordeaux
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Lyon
country: France
facility: University Hospital Lyon
city: Toulouse
country: France
facility: University Cancer Institute Oncopole
city: Halle/Saale
country: Germany
facility: University Hospital Halle/Saale
city: Munich
country: Germany
facility: University Hospital Munich
city: Rostock
country: Germany
facility: University Hospital Rostock
Study officials:
affiliation: Oncologikum Frankfurt
name: Dieter Hoelzer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: