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NCT01472107 Clinical Trial

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

Pregnancy Clinical Trial

— APL0511  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01472107
Other study ID # APL0511
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 7, 2012
Est. completion date June 14, 2019

Study information
Verified date October 2022
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date June 14, 2019
Est. primary completion date June 14, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy 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

Sponsors (1)
Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Children's health Children's health and follow-up data at 24 months from study entry
Secondary 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
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