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

NCT03933852 | Unknown

• 1 other identifier: Ponderosa
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia, Chronic Phase

Outcome Measures

Primary Outcomes (2)

• Change in Cytogenetic response

  Achievement of cytogenetic Response (percentage of Ph+ metaphases)

  through study completion, an average of 3 years

• Molecular response

  BCR-ABL in % (lower is better)

  through study completion, an average of 3 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

University Hospital Jena

Jena, 07747, Germany

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Hochhaus

  University Hospital Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinic of Internal Medicine II

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: May 1, 2019
• Study Start: July 8, 2015
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)