Chronic Myeloid Leukemia, Chronic PhasePonderosaNCT03933852
Observational Study on Chronic Myeloid Leukemia Patients in Any Phase Treated With Ponatinib (Iclusig®) at Any Dose
An observational study of Chronic Myeloid Leukemia, Chronic Phase, run by University of Jena at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Phase
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jul 2015to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cytogenetic response
Achievement of cytogenetic Response (percentage of Ph+ metaphases)
Measured: through study completion, an average of 3 years
Molecular response
BCR-ABL in % (lower is better)
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start8 Jul 2015
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia, Chronic PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas Hochhaus, University of Jena
- Investigators
- Andreas Hochhaus, Principal investigator, University Hospital Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933852
- Sponsor's protocol ID
- Ponderosa
- Acronym
- Ponderosa
- Status last verified
- May 2023
- First submitted
- 8 Apr 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Chronic Myeloid Leukemia Patients in Any Phase Treated With Ponatinib (Iclusig®) at Any Dose
- ClinicalTrials.gov ID
- NCT03933852
- Acronym / sponsor ID
- Ponderosa / Ponderosa
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 8 Jul 2015 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Hochhaus principal investigator
University Hospital Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, Chronic Phase, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cytogenetic response (time frame: through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.