Status:
COMPLETED
Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Acute Promyelocytic Leukemia
Pregnancy
Eligibility:
FEMALE
18-50 years
Brief Summary
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 enro...
Detailed Description
Acute promielocitic leukaemia (APL) Among all the AML subtypes, APL has the distinction of being the most curable. The median age at diagnosis is 40 years, which is younger than with other AML subtype...
Eligibility Criteria
Inclusion
- 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
- Patients aged \< 18 and \> 50 years;
- Patients receiving chemotherapy;
- Concomitant psychiatric disorder that would interfere or prevent the subject from participating in the study.
Key Trial Info
Start Date :
March 7 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 14 2019
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01472107
Start Date
March 7 2012
End Date
June 14 2019
Last Update
October 12 2022
Active Locations (36)
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1
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
2
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, Italy
3
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, Italy, 70010
4
Ospedali Riuniti di Bergamo
Bergamo, Italy