Study of Pregnancy in Patients With Myeloproliferative Neoplasms

September 16, 2026 updated by: University Health Network, Toronto

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dawn Maze, MD, FRCPC, MSc.
  • Phone Number: 5845 416-946-4501
  • Email: dawn.maze@uhn.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with MPN who are pregnant

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants with myeloproliferative neoplasms and are pregnant
Other: Risk-adapted algorithm

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of pregnancies resulting in live birth
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of perinatal venous thrombotic events
Time Frame: 3 years
3 years
Number of arterial thromboembolic events
Time Frame: 3 years
3 years
Number of perinatal major bleeding events
Time Frame: 3 years
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
3 years
Number of hypertensive disorder events of pregnancy at less than 34 weeks
Time Frame: 3 years
3 years
Number of hypertensive disorder events of pregnancy at greater than 34 weeks
Time Frame: 3 years
3 years
Number of participants diagnosed with placental insufficiency
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Dawn Maze, MD, FRCPC, MSc., The Princess Margaret Cancer Foundation
  • Principal Investigator: Nadine Shehata, MD, FRCPC, MSc., Sinai Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 5, 2026

Primary Completion (Estimated)

October 5, 2028

Study Completion (Estimated)

October 5, 2028

Study Registration Dates

First Submitted

September 16, 2026

First Submitted That Met QC Criteria

September 16, 2026

First Posted (Actual)

September 22, 2026

Study Record Updates

Last Update Posted (Actual)

September 22, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAPP-MPN TRIAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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