Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Study on Number and Outcome of Pregnancy in Childbearing Age Female Patients Treated With Chemotherapy for APL (Studies AIDA 0493, AIDA 2000)

Conditions
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Acute Promyelocytic Leukemia, Pregnancy

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of pregnancies | The primary objective is to describe pregnancies in female patients treated with AIDA0493, AIDA2000 studies. | At 24 monhts from study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's health | Children's health and follow-up data | at 24 months from study entry | 
| Pregnancies evolution | Pregnancies evolution and outcome, children health and follow-up data according to AIDA0493 and AIDA2000 treatment strategies | At 24 months from study entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, APL female patients