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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03515785
Date of registration:	23/04/2018
Prospective Registration:	Yes
Primary sponsor:	Incyte Biosciences International Sàrl
Public title:	A Study to Evaluate Effectiveness and Safety of Ponatinib in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"
Scientific 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"
Date of first enrolment:	December 31, 2018
Target sample size:	0
Recruitment status:	Withdrawn
URL:	https://clinicaltrials.gov/show/NCT03515785
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Austria	Czechia	France	Germany

Contacts

Name:	Dieter Hoelzer, Prof. Dr. med.
Address:
Telephone:
Email:
Affiliation:	Oncologikum Frankfurt

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

BCR-ABL Positive Acute Lymphoblastic Leukemia

Intervention(s)

Primary Outcome(s)

Complete hematological remission (CR) rate [Time Frame: 6 months]

Secondary Outcome(s)

Best MRD (MolR) level rate [Time Frame: 12 months]

Duration of best molecular response (MolCR) [Time Frame: Up to 12 months]

Time to best MRD (MolR) level [Time Frame: Up to 12 months]

Prescribed dose [Time Frame: Up to 12 months]

Amount of hospital days [Time Frame: 12 months]

Time to progression [Time Frame: Up to 12 months]

Time to CR [Time Frame: Up to 12 months]

Daily average dose [Time Frame: Up to 12 months]

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

Number of adverse events of special interest (AESI) [Time Frame: 12 months]

CR rate [Time Frame: 1, 3, 6, 9, and 12 months]

CR rate [Time Frame: 1, 3, 9, and 12 months]

Duration of molecular response [Time Frame: Up to 12 months]

Number of serious adverse events (SAEs) [Time Frame: 12 months]

Time to death [Time Frame: Up to 12 months]

Secondary ID(s)

INCB-DEMA-ALL-401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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