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

Chronic Myeloid Leukemia, Chronic Phase Clinical Trial

— Ponderosa  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03933852
• Other study ID #: Ponderosa
• Status: Active, not recruiting
• Start date: July 8, 2015
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia, Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Locations

Country	Name	City	State
Germany	University Hospital Jena	Jena

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cytogenetic response	Achievement of cytogenetic Response (percentage of Ph+ metaphases)	through study completion, an average of 3 years
Primary	Molecular response	BCR-ABL in % (lower is better)	through study completion, an average of 3 year