Clinical trial · Observational
Monitoring the Diagnosis and Management of Acute Leukaemia In Pregnancy Study.
A Prospective Registry-based Cohort Study to Monitor the Diagnosis and Management of Acute Leukaemia in Pregnancy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Acute leukaemia (AL) is an aggressive but potentially curable cancer that can affect women of childbearing age. When a pregnancy is complicated by a diagnosis of AL, clinicians face a complex dilemma: to balance risking the mother's survival through delaying treatment, against the potential harm to the foetus through exposure to cancer drugs. Reports suggest that, providing the first trimester is avoided, successful treatment of AL during pregnancy is possible, and considered safe. However, there is currently no standard approach to treatment of these women. This observational study aims to monitor and record the current treatment and outcomes of patients diagnosed with acute leukaemia during or prior to pregnancy. Patients will receive the treatment recommended by their doctor, the study will not alter the treatment pathway of participants. This study will establish a new research database of Leukaemia in Pregnancy, initially collecting data from cases since August 2009, and any new cases that are diagnosed during the current funding period. The initial planned analyses from this dataset will enable more robust, evidence-based recommendations to be made on how to monitor and manage these patients, and will add value to and improve the existing British Committee for Standards in Haematology (BCSH) guidelines, which were largely derived from expert opinion. This should enable healthcare professionals to have greater confidence in managing these patients, leading to a more standardised approach to providing high quality care. The study will benefit National Health Service (NHS) Trusts and patients across the United Kingdom (UK) through more informed clinical decision making with regards to the care they receive. It will also provide an important data resource which researchers can apply to use in further analyses, with plans to continue data collection if further funding is obtained.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Number of deaths and complications during pregnancy and up to one month after delivery.
- timeFrame
- Up to 1 month after delivery.
- description
- Morbidity and mortality outcomes of women treated for AL or high-risk MDS during pregnancy.
- measure
- Number of neonatal deaths and complications during pregnancy and up to one month after delivery.
- timeFrame
- Up to 1 month after delivery.
- description
- Short term morbidity and mortality outcomes for neonates born by women who were treated for AL or high-risk MDS during pregnancy.
- measure
- Number of deaths and complications during pregnancy.
- timeFrame
- Up to 1 month after delivery.
- description
- Morbidity and mortality outcomes during pregnancy of women previously treated for AL or high-risk MDS.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Women who have a diagnosis of acute leukaemia (AL) or high-risk myelodysplasia (MDS) in pregnancy, or who have later conceived after receiving previous treatment for either AL or high-risk MDS. Exclusion Criteria: * Pregnant women not meeting the inclusion criterion.
References
Publications (2)
- BACKGROUNDAli S, Jones GL, Culligan DJ, Marsden PJ, Russell N, Embleton ND, Craddock C; British Committee for Standards in Haematology. Guidelines for the diagnosis and management of acute myeloid leukaemia in pregnancy. Br J Haematol. 2015 Aug;170(4):487-95. doi: 10.1111/bjh.13554. Epub 2015 Jun 17. PMID 26081614
- BACKGROUNDNorthgraves M, Allsup D, Cohen J, Huang C, Turgoose J, Ali S. A prospective registry-based cohort study of the diagnosis and management of acute leukaemia in pregnancy: Study protocol. PLoS One. 2022 Feb 7;17(2):e0263195. doi: 10.1371/journal.pone.0263195. eCollection 2022. PMID 35130292