Brief Title
Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy
Official Title
Observational Study on Number and Outcome of Pregnancy in Childbearing Age Female Patients Treated With Chemotherapy for APL (Studies AIDA 0493, AIDA 2000)
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 enrolled in studies AIDA0493, AIDA2000 and were in CR.
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 subtypes. The fact that APL is more common in younger patients increases the
likelihood that it may occur during fertile age. The introduction of ATRA and ATO has
substantially modified the outcome of APL: in two successive studies 94% of patients achieved
CR and the 6-yr OS rates (PETHEMA and GIMEMA) were about 80% 2,3,6.
ATRA is highly effective in APL patients, but adverse effects such as retinoic acid syndrome,
arrhythmias, headache, rash, dizziness have been reported. Moreover, retinoids are known to
be potent teratogens and increased rates of spontaneous abortion and major fetal
abnormalities have been reported 10. Most of the cases reported suggest that ATRA is
relatively safe for both mother and fetus when used in the second and third trimesters. By
contrast, when it was used in the first trimester, a negative foetal outcome was reported. No
data have yet been reported on the outcomes of pregnancies in young patients with APL,
occurring during CCR following ATRA-including chemotherapy regimens.
APL therapy AIDA regimen: simultaneous Atra plus IDArubicin (AIDA) combination for induction
treatment, followed by 3 courses of intensive chemotherapy as consolidation2.
Consolidation therapy in the AIDA-0493 trial consisted of 3 chemotherapy courses with Ara-C
and idarubicin3.
Consolidation treatment in the AIDA-2000 was given according to a risk-adapted strategy as
follows: patients with low-/intermediate-risk received the same 3 consolidation courses as in
the AIDA-0493 but with omission of cytarabine; patients in the high-risk group received the
identical 3 cycles as in the AIDA-0493.
Study rationale This is 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 studies AIDA0493, AIDA2000 and were in CR.
Study Type
Observational
Primary Outcome
Description of pregnancies
Secondary Outcome
Children's health
Condition
Acute Promyelocytic Leukemia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
69
Start Date
March 7, 2012
Completion Date
June 14, 2019
Primary Completion Date
June 14, 2019
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
Giogina SPECCHIA, Pr., ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT01472107
Organization ID
APL0511
Responsible Party
Sponsor
Study Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Sponsor
Giogina SPECCHIA, Pr., Principal Investigator, UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Verification Date
October 2022