Myeloproliferative Neoplasm (MPN)NCT07832513
Study of Pregnancy in Patients With Myeloproliferative Neoplasms
An observational study of Myeloproliferative Neoplasm (MPN) and Pregnancy, run by University Health Network, Toronto.
Trial summary
This is a study to evaluate pregnancy in patients with myeloproliferative neoplasms. The main endpoint of this study is to determine the number of live births in pregnant MPN patients who are managed by a risk-adapted algorithm Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Myeloproliferative Neoplasm (MPN), Pregnancy
- What is being tested?
- Risk-adapted algorithm
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2026to 5 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with MPN who are pregnant
Who may be able to join
- Patients with a diagnosis of chronic phase essential thrombocythemia (ET), polycythemia vera (PV), prefibrotic or overt primary myelofibrosis (PMF), post-ET myelofibrosis (MF), post-PV MF, or myeloproliferative neoplasm (MPN) - unclassifiable according to the 2022 International Consensus Criteria. Patients who have not had a diagnostic bone marrow biopsy may participate if there is a driver mutation and all other diagnostic criteria are met.
- Patients with a confirmed pregnancy through Beta Human Chorionic Gonadotropin (BHCG) testing of the urine or blood and/or dating ultrasound. Patients may be eligible to participate at any stage of pregnancy.
- Patients must have the ability to participate in study procedures.
- Participants must provide consent to participate in this study.
Who cannot join
- Patients with a diagnosis of chronic myeloid leukemia, myelodysplastic syndrome (MDS), MDS/MPN overlap syndrome, or other myeloid malignancy.
- Peripheral blood or marrow blasts >/= 10%.
- Patients with concurrent disease that in the opinion of the investigator may be adversely impact the safety of the patient or impair assessment of study results, including but not limited to:
- Uncontrolled autoimmune diseases (e.g., hepatitis, immune thrombocytopenic purpura [ITP], scleroderma, autoimmune arthritis)
- Active, uncontrolled infection (e.g., HIV, hepatitis B, hepatitis C)
- Second malignancy requiring concurrent treatment, except basal cell carcinoma or squamous cell carcinoma or cervical carcinoma in situ.
- Patients requiring a legally authorized representative.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Multicentre Study to Evaluate Maternal and Perinatal Outcomes in Myeloproliferative Neoplasms: MAPP-MPN Trial
This is a study to evaluate pregnancy in patients with myeloproliferative neoplasms. The main endpoint of this study is to determine the number of live births in pregnant MPN patients who are managed by a risk-adapted algorithm
- Conditions
- Myeloproliferative Neoplasm (MPN), Pregnancy
- Being tested
- Risk-adapted algorithm
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-adapted algorithmOther
The risk-based algorithm is based on expert consensus and has been well-described in review articles and educational sessions at major conferences.
| Study group | Role | What they receive |
|---|---|---|
| Participants with myeloproliferative neoplasms and are pregnant | Not described Receives: Other: Risk-adapted algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of pregnancies resulting in live birth
Measured: 3 years
Secondary outcomes (7)
Number of perinatal venous thrombotic events
Measured: 3 years
Number of arterial thromboembolic events
Measured: 3 years
Number of perinatal major bleeding events
Measured: 3 years
Proportion of participant deaths from any cause, starting from the beginning of the pregnancy up until 12 weeks after the pregnancy ends.
Measured: 3 years
Number of hypertensive disorder events of pregnancy at less than 34 weeks
Measured: 3 years
Number of hypertensive disorder events of pregnancy at greater than 34 weeks
Measured: 3 years
Number of participants diagnosed with placental insufficiency
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start5 Oct 2026 (estimated)
- Primary completion5 Oct 2028 (estimated)
- Study completion5 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative Neoplasm (MPN)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawn Maze, MD, FRCPC, MSc., Principal investigator, The Princess Margaret Cancer FoundationNadine Shehata, MD, FRCPC, MSc., Principal investigator, Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832513
- Sponsor's protocol ID
- MAPP-MPN TRIAL
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentre Study to Evaluate Maternal and Perinatal Outcomes in Myeloproliferative Neoplasms: MAPP-MPN Trial
- ClinicalTrials.gov ID
- NCT07832513
- Acronym / sponsor ID
- MAPP-MPN TRIAL
- Conditions
- Myeloproliferative Neoplasm (MPN), Pregnancy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 5 Oct 2028 (estimated)
- Study completion
- 5 Oct 2028 (estimated)
- First posted
- 22 Sep 2026 (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.
This is a study to evaluate pregnancy in patients with myeloproliferative neoplasms. The main endpoint of this study is to determine the number of live births in pregnant MPN patients who are managed by a risk-adapted algorithm
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with myeloproliferative neoplasms and are pregnant | – | Other: Risk-adapted algorithm |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with MPN who are pregnant
Key inclusion criteria (4 listed)
- Patients with a diagnosis of chronic phase essential thrombocythemia (ET), polycythemia vera (PV), prefibrotic or overt primary myelofibrosis (PMF), post-ET myelofibrosis (MF), post-PV MF, or myeloproliferative neoplasm (MPN) - unclassifiable according to the 2022 International Consensus Criteria. Patients who have not had a diagnostic bone marrow biopsy may participate if there is a driver mutation and all other diagnostic criteria are met.
- Patients with a confirmed pregnancy through Beta Human Chorionic Gonadotropin (BHCG) testing of the urine or blood and/or dating ultrasound. Patients may be eligible to participate at any stage of pregnancy.
- Patients must have the ability to participate in study procedures.
- Participants must provide consent to participate in this study.
Key exclusion criteria (7 listed)
- Patients with a diagnosis of chronic myeloid leukemia, myelodysplastic syndrome (MDS), MDS/MPN overlap syndrome, or other myeloid malignancy.
- Peripheral blood or marrow blasts >/= 10%.
- Patients with concurrent disease that in the opinion of the investigator may be adversely impact the safety of the patient or impair assessment of study results, including but not limited to:
- Uncontrolled autoimmune diseases (e.g., hepatitis, immune thrombocytopenic purpura [ITP], scleroderma, autoimmune arthritis)
- Active, uncontrolled infection (e.g., HIV, hepatitis B, hepatitis C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-adapted algorithmThe risk-based algorithm is based on expert consensus and has been well-described in review articles and educational sessions at major conferences. | Other | Participants with myeloproliferative neoplasms and are pregnant |
Primary outcome
Proportion of pregnancies resulting in live birth
Time frame: 3 years
7 secondary outcomes
Number of perinatal venous thrombotic events
Time frame: 3 years
Number of arterial thromboembolic events
Time frame: 3 years
Number of perinatal major bleeding events
Time frame: 3 years
Proportion of participant deaths from any cause, starting from the beginning of the pregnancy up until 12 weeks after the pregnancy ends.
Time frame: 3 years
Number of hypertensive disorder events of pregnancy at less than 34 weeks
Time frame: 3 years
Number of hypertensive disorder events of pregnancy at greater than 34 weeks
Time frame: 3 years
Number of participants diagnosed with placental insufficiency
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- 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.
Dawn Maze, MD, FRCPC, MSc. principal investigator
The Princess Margaret Cancer Foundation
Nadine Shehata, MD, FRCPC, MSc. principal investigator
Sinai Health System
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm (MPN) and Pregnancy, run by University Health Network, Toronto.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dawn Maze, MD, FRCPC, MSc. (416-946-4501 ext. 5845, dawn.maze@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of pregnancies resulting in live birth (time frame: 3 years). 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 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.