Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy
Conditions
Acute Promyelocytic Leukemia - Pregnancy
Conditions: official terms
Leukemia, Promyelocytic, Acute
Conditions: Keywords
Pregnancy, APL female patients
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Retrospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 50 Years
Minimum Age: 18 Years
Gender: Female
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.
Locations
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Status: Recruiting
Contact: Lorella De Paoli, Dr.
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, Italy
Status: Recruiting
Contact: Pietro Leoni
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, Italy
Status: Recruiting
Contact: Giorgina SPECCHIA, Pr.
Ospedali Riuniti di Bergamo
Bergamo, Italy
Status: Recruiting
Contact: Alessandro Rambaldi, Pr.
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
Bologna, Italy
Status: Recruiting
Contact: Giovanni MARTINELLI, Pr. - martg@tin.it
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
Bolzano, Italy
Status: Not yet recruiting
Contact: Vincenzo Cassibba, Dr.
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, Italy
Status: Recruiting
Contact: Erika BORLENGHI, Dr. - erika.ok@libero.it
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, Italy
Status: Recruiting
Contact: Stefano Molica, Dr.
Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
Cremona, Italy
Status: Not yet recruiting
Contact: Francesco Lanza, Pr.
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, Italy
Status: Recruiting
Contact: Antonio CUNEO, Pr.
Policlinico di Careggi, Università delgi studi di Firenze
Firenze, Italy
Status: Recruiting
Contact: Alberto BOSI
Clinica Ematologica - DiMI - Università degli Studi di Genova
Genova, Italy
Status: Not yet recruiting
Contact: Marco Gobbi, Pr.
Divisione di Ematologia Ospedale "Santa Maria Goretti"
Latina, Italy
Status: Recruiting
Contact: Angelo De Blasio, Dr.
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Messina, Italy
Status: Recruiting
Contact: Caterina Musolino, Pr.
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina, Italy
Status: Recruiting
Contact: Maura Brugiatelli, Dr.
Ospedale Niguarda " Ca Granda"
Milano, Italy
Status: Recruiting
Contact: Anna Maria Nosari, Dr.
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
Milano, Italy
Status: Recruiting
Contact: Elena Guggiari, Dr.
Centro Oncologico Modenese - Dipartimento di Oncoematologia
Modena, Italy
Status: Recruiting
Contact: Mario Luppi, Dr.
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori"
Monza, Italy
Status: Recruiting
Contact: Monica Fumagalli, Dr.
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, Italy
Status: Recruiting
Contact: Fabrizio Pane, Pr.
Ospedale S. Gennaro ASL NA1
Napoli, Italy
Status: Recruiting
Contact: Lucia MASTRULLO, Dr.
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
Palermo, Italy
Status: Not yet recruiting
Contact: Maria Enza Mitra, Dr.
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, Italy
Status: Recruiting
Contact: Rosaria Felice, Dr.
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma, Italy
Status: Recruiting
Contact: Cecilia CARAMATTI, Dr.
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della MIsericordia
Perugia, Italy
Status: Recruiting
Contact: Brunangelo Falini, Pr.
Istituto di Ematologia- Ospedale San Carlo
Potenza, Italy
Status: Recruiting
Contact: Michele PIZZUTI
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, Italy
Status: Recruiting
Contact: Francesco NOBILE, Pr.
Vulture U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture, Italy
Status: Recruiting
Contact: Pellegrino Musto, Dr.
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
Status: Recruiting
Contact: Simona SICA, Dr.
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, Italy
Status: Recruiting
Contact: Roberto Foà
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
S. G. Rotondo, Italy
Status: Recruiting
Contact: Nicola Cascavilla, Dr.
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena, Italy
Status: Recruiting
Contact: Monica Bocchia, Pr.
U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
Taranto, Italy
Status: Not yet recruiting
Contact: Emilio Iannitto, Dr.
SCDO Ematologia 2 AOU S.Giovanni Battista
Torino, Italy
Status: Recruiting
Contact: Stefano D'Ardia, Dr.
Clinica Ematologica - Policlinico Universitario
Udine, Italy
Status: Recruiting
Contact: Anna Candoni, Dr.
Ospedale San Bortolo
Vicenza, Italy
Status: Recruiting
Contact: Eros DI BONA, Pr. - dibona@hemato.ven.it
Start Date
February 2012
Completion Date
December 2015
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Source
Gruppo Italiano Malattie EMatologiche dell'Adulto
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page