Clinical trial · Observational
Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy
Observational Study on Number and Outcome of Pregnancy in Childbearing Age Female Patients Treated With Chemotherapy for APL (Studies AIDA 0493, AIDA 2000)
NCT01472107CI-TRIAL-00061414APL0511completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The GIMEMA FOUNDATION promotes an observational (retrospective) study on number and outcome of pregnancy in childbearing age female patients treated with chemotherapy for APL. These patients were enrolled in studies AIDA0493, AIDA2000 and were in CR.
Conditions
Conditions (2)
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 Promyelocytic Leukemia | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Pregnancy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Description of pregnancies
- timeFrame
- At 24 monhts from study entry
- description
- The primary objective is to describe pregnancies in female patients treated with AIDA0493, AIDA2000 studies.
Secondary outcomes (2)
- measure
- Children's health
- timeFrame
- at 24 months from study entry
- description
- Children's health and follow-up data
- measure
- Pregnancies evolution
- timeFrame
- At 24 months from study entry
- description
- Pregnancies evolution and outcome, children health and follow-up data according to AIDA0493 and AIDA2000 treatment strategies
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Patients alive aged between 18 and 50 years * Patients with unequivocal diagnosis of APL according to the FAB classification or WHO 2008 diagnostic criteria. Female in childbearing age treated for APL, enrolled in the studies AIDA0493, AIDA2000 in CR after 2 years of maintenance with the exclusion of those randomized to observation in the AIDA2000, AIDA0493 Exclusion Criteria: * Patients aged \< 18 and \> 50 years; * Patients receiving chemotherapy; * Concomitant psychiatric disorder that would interfere or prevent the subject from participating in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.