Observational Study on Chronic Myeloid Leukemia Patients in Any Phase Treated With Ponatinib (Iclusig®) at Any Dose (Ponderosa)
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|ClinicalTrials.gov Identifier: NCT03933852|
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : September 10, 2020
|Condition or disease|
|Chronic Myeloid Leukemia, Chronic Phase|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Observational Study on Chronic Myeloid Leukemia Patients in Any Phase Treated With Ponatinib (Iclusig®) at Any Dose|
|Actual Study Start Date :||July 8, 2015|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
- Change in Cytogenetic response [ Time Frame: through study completion, an average of 3 years ]Achievement of cytogenetic Response (percentage of Ph+ metaphases)
- Molecular response [ Time Frame: through study completion, an average of 3 year ]BCR-ABL in % (lower is better)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933852
|Contact: Andreas Hochhaus, Prof. Dr.||+49 firstname.lastname@example.org|
|University Hospital Jena||Recruiting|
|Jena, Germany, 07747|
|Contact: Andreas Hochhaus, Prof. Dr.|
|Principal Investigator:||Andreas Hochhaus||University Hospital Jena|