Spots Global Cancer Trial Database for Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy
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Trial Identification
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)
Study ID: NCT01472107
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, Firenze, , 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", Milano, , Italy
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele, Milano, , 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
Contact Details
Name: Giogina SPECCHIA, Pr.
Affiliation: UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Role: PRINCIPAL_INVESTIGATOR
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