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Clinical Trials/NCT07832513
NCT07832513Not yet recruitingNot Applicable

A Prospective Multicentre Study to Evaluate Maternal and Perinatal Outcomes in Myeloproliferative Neoplasms: MAPP-MPN Trial

University Health Network, Toronto0 sites30 target enrollmentStarted: October 5, 2026Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Primary Endpoint
Proportion of pregnancies resulting in live birth
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

Participants with myeloproliferative neoplasms and are pregnant

Intervention: Risk-adapted algorithm (Other)

Outcomes

Primary Outcomes

Proportion of pregnancies resulting in live birth

Time Frame: 3 years

Secondary Outcomes

  • Number of perinatal venous thrombotic events(3 years)
  • Number of arterial thromboembolic events(3 years)
  • Number of perinatal major bleeding events(3 years)
  • Proportion of participant deaths from any cause, starting from the beginning of the pregnancy up until 12 weeks after the pregnancy ends.(3 years)
  • Number of hypertensive disorder events of pregnancy at less than 34 weeks(3 years)
  • Number of hypertensive disorder events of pregnancy at greater than 34 weeks(3 years)
  • Number of participants diagnosed with placental insufficiency(3 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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