- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07832513
Study of Pregnancy in Patients With Myeloproliferative Neoplasms
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Dawn Maze, MD, FRCPC, MSc.
- Telefonnummer: 5845 416-946-4501
- E-mail: dawn.maze@uhn.ca
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients with MPN who are pregnant
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Participants with myeloproliferative neoplasms and are pregnant
|
The risk-based algorithm is based on expert consensus and has been well-described in review articles and educational sessions at major conferences. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of pregnancies resulting in live birth
Tidsramme: 3 years
|
3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of perinatal venous thrombotic events
Tidsramme: 3 years
|
3 years
|
|
Number of arterial thromboembolic events
Tidsramme: 3 years
|
3 years
|
|
Number of perinatal major bleeding events
Tidsramme: 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.
Tidsramme: 3 years
|
3 years
|
|
Number of hypertensive disorder events of pregnancy at less than 34 weeks
Tidsramme: 3 years
|
3 years
|
|
Number of hypertensive disorder events of pregnancy at greater than 34 weeks
Tidsramme: 3 years
|
3 years
|
|
Number of participants diagnosed with placental insufficiency
Tidsramme: 3 years
|
3 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Dawn Maze, MD, FRCPC, MSc., The Princess Margaret Cancer Foundation
- Ledende efterforsker: Nadine Shehata, MD, FRCPC, MSc., Sinai Health System
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MAPP-MPN TRIAL
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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