Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy
NCT ID: NCT01472107
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
69 participants
OBSERVATIONAL
2012-03-07
2019-06-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 receiving chemotherapy;
* Concomitant psychiatric disorder that would interfere or prevent the subject from participating in the study.
18 Years
50 Years
FEMALE
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Giogina SPECCHIA, Pr.
Role: PRINCIPAL_INVESTIGATOR
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Locations
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S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, , Italy
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, , Italy
Ospedali Riuniti di Bergamo
Bergamo, , Italy
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
Bologna, , Italy
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
Bolzano, , Italy
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, , Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, , Italy
Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
Cremona, , Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, , Italy
Policlinico di Careggi, Università delgi studi di Firenze
Florence, , Italy
Clinica Ematologica - DiMI - Università degli Studi di Genova
Genova, , Italy
Divisione di Ematologia Ospedale "Santa Maria Goretti"
Latina, , Italy
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Messina, , Italy
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina, , Italy
Ospedale Niguarda " Ca Granda"
Milan, , Italy
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
Milan, , Italy
Centro Oncologico Modenese - Dipartimento di Oncoematologia
Modena, , Italy
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori"
Monza, , Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, , Italy
Ospedale S. Gennaro ASL NA1
Napoli, , Italy
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
Palermo, , Italy
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, , Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma, , Italy
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della MIsericordia
Perugia, , Italy
Istituto di Ematologia- Ospedale San Carlo
Potenza, , Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Vulture U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture, , Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, , Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, , Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena, , Italy
U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
Taranto, , Italy
SCDO Ematologia 2 AOU S.Giovanni Battista
Torino, , Italy
Clinica Ematologica - Policlinico Universitario
Udine, , Italy
Ospedale San Bortolo
Vicenza, , Italy
Countries
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Related Links
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GIMEMA Foundation Website
Other Identifiers
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APL0511
Identifier Type: -
Identifier Source: org_study_id
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