BCR-ABL Positive Acute Lymphoblastic LeukemiaNCT03515785
A Study to Evaluate Effectiveness and Safety of Ponatinib in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"
An observational study of BCR-ABL Positive Acute Lymphoblastic Leukemia, run by Incyte Biosciences International Sàrl at 10 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BCR-ABL Positive Acute Lymphoblastic Leukemia
- How many people
- 0 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 31 Dec 2018to Mar 2021
- 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: Adult patients with Ph+ ALL being treated with Iclusig® in Europe.
Who may be able to join
- 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.
Who cannot join
- Patients previously treated with investigational ponatinib.
- Patients who are pregnant and/or breastfeeding.
- Concurrent treatment with another tyrosine kinase inhibitor for Ph+ALL.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
France6 sites
University Hospital Amiens
Amiens, 80080
University Hospital Angers
Angers, 49100
University Hospital Bordeaux
Bordeaux, 33000
University Hospital Grenoble
Grenoble, 38700
University Hospital Lyon
Lyon, 69361
University Cancer Institute Oncopole
Toulouse, 31059
Germany3 sites
University Hospital Halle/Saale
Halle, 06120
University Hospital Munich
Munich, 81377
University Hospital Rostock
Rostock, 18057
About this study
Official title: 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.
- Keywords
- acute lymphoblastic leukemia, ponatinib, tyrosine kinase inhibitor
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ph+ ALL Patients | Patients with Ph+ ALL being treated with Iclusig®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (15)
CR rate
CR defined as leukemic cells not detectable by light microscopy in BM, PB, or CSF (BM < 5% blasts).
Measured: 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).
Measured: 1, 3, 6, 9, and 12 months
Time to CR
Defined as time from enrollment to first CR.
Measured: Up to 12 months
Minimal residual disease (MRD) level
Minimal residual disease level.
Measured: 3, 6, 9, and 12 months
Best MRD (MolR) level rate
MolR defined as molecular/MRD response, less than MolCR.
Measured: 12 months
Time to best MRD (MolR) level
MolR defined as molecular/MRD response, less than MolCR.
Measured: Up to 12 months
Duration of molecular response
Measured by MRD log reduction (MolR).
Measured: Up to 12 months
Duration of best molecular response (MolCR)
MolCR defined as complete molecular remission/MRD negativity.
Measured: Up to 12 months
Time to progression
Defined as the time to molecular relapse or hematological relapse.
Measured: Up to 12 months
Time to death
Defined as time from enrollment to death due to any cause.
Measured: Up to 12 months
Prescribed dose
Prescribed dose of Iclusig® in milligrams.
Measured: Up to 12 months
Daily average dose
The average daily dose of Iclusig® in milligrams.
Measured: 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.
Measured: 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.
Measured: 12 months
Amount of hospital days
Defined as overnight stay(s), each night in the hospital will be counted as 1 day.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start31 Dec 2018 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: Revisiting the availability of patients with Ph+ ALL that would meet the in-/exclusion criteria of the study led to the decision not to move forward.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCR-ABL Positive Acute Lymphoblastic LeukemiaStudies 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
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Biosciences International Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dieter Hoelzer, Prof. Dr. med., Principal investigator, Oncologikum Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515785
- Sponsor's protocol ID
- INCB-DEMA-ALL-401
- Status last verified
- Dec 2018
- First submitted
- 23 Apr 2018
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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"
- ClinicalTrials.gov ID
- NCT03515785
- Acronym / sponsor ID
- INCB-DEMA-ALL-401
- Keywords
- acute lymphoblastic leukemia, ponatinib, tyrosine kinase inhibitor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Revisiting the availability of patients with Ph+ ALL that would meet the in-/exclusion criteria of the study led to the decision not to move forward.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Incyte Biosciences International SàrlIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2018 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 4 May 2018 (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.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ph+ ALL Patients | – | –Patients with Ph+ ALL being treated with Iclusig®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Ph+ ALL being treated with Iclusig® in Europe.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients previously treated with investigational ponatinib.
- Patients who are pregnant and/or breastfeeding.
- Concurrent treatment with another tyrosine kinase inhibitor for Ph+ALL.
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
Complete hematological remission (CR) rate
Time frame: 6 months
CR defined as leukemic cells not detectable by light microscopy in bone marrow (BM), peripheral blood (PB), or cerebrospinal fluid (CSF) (BM < 5% blasts).
15 secondary outcomes
CR rate
Time frame: 1, 3, 9, and 12 months
CR rate
Time frame: 1, 3, 6, 9, and 12 months
Time to CR
Time frame: Up to 12 months
Minimal residual disease (MRD) level
Time frame: 3, 6, 9, and 12 months
Best MRD (MolR) level rate
Time frame: 12 months
Time to best MRD (MolR) level
Time frame: Up to 12 months
Duration of molecular response
Time frame: Up to 12 months
Duration of best molecular response (MolCR)
Time frame: Up to 12 months
Time to progression
Time frame: Up to 12 months
Time to death
Time frame: Up to 12 months
Prescribed dose
Time frame: Up to 12 months
Daily average dose
Time frame: Up to 12 months
Number of serious adverse events (SAEs)
Time frame: 12 months
Number of adverse events of special interest (AESI)
Time frame: 12 months
Amount of hospital days
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- 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.
Dieter Hoelzer, Prof. Dr. med. principal investigator
Oncologikum Frankfurt
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BCR-ABL Positive Acute Lymphoblastic Leukemia, run by Incyte Biosciences International Sàrl at 10 sites in 3 countries.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Germany, Czechia. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Complete hematological remission (CR) rate (time frame: 6 months). 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 14 Dec 2018.