Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy (APL0511)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01472107
First received: November 11, 2011
Last updated: May 6, 2014
Last verified: May 2014

November 11, 2011
May 6, 2014
February 2012
December 2014   (final data collection date for primary outcome measure)
Description of pregnancies [ Time Frame: At 24 monhts from study entry ] [ Designated as safety issue: No ]
The primary objective is to describe pregnancies in female patients treated with AIDA0493, AIDA2000 studies.
Same as current
Complete list of historical versions of study NCT01472107 on ClinicalTrials.gov Archive Site
  • Children's health [ Time Frame: at 24 months from study entry ] [ Designated as safety issue: No ]
    Children's health and follow-up data
  • Pregnancies evolution [ Time Frame: At 24 months from study entry ] [ Designated as safety issue: No ]
    Pregnancies evolution and outcome, children health and follow-up data according to AIDA0493 and AIDA2000 treatment strategies
Same as current
Not Provided
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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)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

The patients enrolled in studies AIDA0493, AIDA2000 in CR .

  • Acute Promyelocytic Leukemia Female Patients
  • Pregnancy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years to 50 Years
No
Contact: Paola FAZI, Dr. p.fazi@gimema.it
Contact: Enrico CREA e.crea@gimema.it
Italy
 
NCT01472107
APL0511
No
Gruppo Italiano Malattie EMatologiche dell'Adulto
Gruppo Italiano Malattie EMatologiche dell'Adulto
Not Provided
Principal Investigator: Giogina SPECCHIA, Pr. UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Gruppo Italiano Malattie EMatologiche dell'Adulto
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP