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NCT Number: NCT07832513

Study of Pregnancy in Patients With Myeloproliferative Neoplasms

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risk-adapted algorithm

Other

The risk-based algorithm is based on expert consensus and has been well-described in review articles and educational sessions at major conferences.

Primary outcomes

  1. Proportion of pregnancies resulting in live birth

    Time frame: 3 years

Secondary outcomes

  1. Number of perinatal venous thrombotic events

    Time frame: 3 years

  2. Number of arterial thromboembolic events

    Time frame: 3 years

  3. Number of perinatal major bleeding events

    Time frame: 3 years

  4. 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

  5. Number of hypertensive disorder events of pregnancy at less than 34 weeks

    Time frame: 3 years

  6. Number of hypertensive disorder events of pregnancy at greater than 34 weeks

    Time frame: 3 years

  7. Number of participants diagnosed with placental insufficiency

    Time frame: 3 years

Interested in participating?

Not yet recruiting

Trial opening soon.

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Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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