Health TrialsbyHealthPanel

Study of Pregnancy in Patients With Myeloproliferative Neoplasms

ConditionsMyeloproliferative Neoplasm (MPN)Pregnancy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorUniversity Health Network, Toronto

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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%.

Uncontrolled autoimmune diseases (e.g., hepatitis, immune thrombocytopenic purpura [ITP], scleroderma, autoimmune arthritis)

Active, uncontrolled infection (e.g., HIV, hepatitis B, hepatitis C)

Trial population

Patients with MPN who are pregnant

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Risk-adapted algorithm

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Participants with myeloproliferative neoplasms and are pregnant1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: