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

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"

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.

Study Overview

• Status: Withdrawn
• Conditions: BCR-ABL Positive Acute Lymphoblastic Leukemia

• Study Type: Observational

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 128 00
    • Ihbt/Úhkt
• France
  • Amiens, France, 80080
    • University Hospital Amiens
  • Angers, France, 49100
    • University Hospital Angers
  • Bordeaux, France, 33000
    • University Hospital Bordeaux
  • Grenoble, France, 38700
    • University Hospital Grenoble
  • Lyon, France, 69361
    • University Hospital Lyon
  • Toulouse, France, 31059
    • University Cancer Institute Oncopole
• Germany
  • Halle/Saale, Germany, 06120
    • University Hospital Halle/Saale
  • Munich, Germany, 81377
    • University Hospital Munich
  • Rostock, Germany, 18057
    • University Hospital Rostock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Ph+ ALL being treated with Iclusig® in Europe.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CR rate	CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM < 5% blasts).	1, 3, 9, and 12 months
CR rate	CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM < 5% blasts).	1, 3, 6, 9, and 12 months
Time to CR	Defined as time from enrollment to first CR.	Up to 12 months
Minimal residual disease (MRD) level	Minimal residual disease level.	3, 6, 9, and 12 months
Best MRD (MolR) level rate	MolR defined as molecular/MRD response, less than MolCR.	12 months
Time to best MRD (MolR) level	MolR defined as molecular/MRD response, less than MolCR.	Up to 12 months
Duration of molecular response	Measured by MRD log reduction (MolR).	Up to 12 months
Duration of best molecular response (MolCR)	MolCR defined as complete molecular remission/MRD negativity.	Up to 12 months
Time to progression	Defined as the time to molecular relapse or hematological relapse.	Up to 12 months
Time to death	Defined as time from enrollment to death due to any cause.	Up to 12 months
Prescribed dose	Prescribed dose of Iclusig® in milligrams.	Up to 12 months
Daily average dose	The average daily dose of Iclusig® in milligrams.	Up to 12 months
Number of serious adverse events (SAEs)	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.	12 months
Number of adverse events of special interest (AESI)	AESI defined as vascular occlusive events, including arterial and venous events, as defined in the protocol.	12 months
Amount of hospital days	Defined as overnight stay(s), each night in the hospital will be counted as 1 day.	12 months

Collaborators and Investigators

• Sponsor: Incyte Biosciences International Sàrl
• Investigators: Principal Investigator: Dieter Hoelzer, Prof. Dr. med., Oncologikum Frankfurt

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2018
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): December 14, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: tyrosine kinase inhibitor; acute lymphoblastic leukemia; ponatinib
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: INCB-DEMA-ALL-401

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 device product: No