Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy
APL0511
Observational Study on Number and Outcome of Pregnancy in Childbearing Age Female Patients Treated With Chemotherapy for APL (Studies AIDA 0493, AIDA 2000)
1 other identifier
observational
69
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2012
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2011
CompletedFirst Posted
Study publicly available on registry
November 16, 2011
CompletedStudy Start
First participant enrolled
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2019
CompletedOctober 12, 2022
October 1, 2022
7.3 years
November 11, 2011
October 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Children's health
at 24 months from study entry
Pregnancies evolution
At 24 months from study entry
Eligibility Criteria
The patients enrolled in studies AIDA0493, AIDA2000 in CR .
You may qualify if:
- Patients alive aged between 18 and 50 years
- Patients with unequivocal diagnosis of APL according to the FAB classification or WHO 2008 diagnostic criteria.
You may not qualify if:
- Patients aged \< 18 and \> 50 years;
- Patients receiving chemotherapy;
- Concomitant psychiatric disorder that would interfere or prevent the subject from participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
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, 70010, Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
Bologna, 40138, Italy
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
Bolzano, Italy
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, 21125, 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, 44100, 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, 89100, Italy
Vulture U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, 00168, 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, 36100, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giogina SPECCHIA, Pr.
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2011
First Posted
November 16, 2011
Study Start
March 7, 2012
Primary Completion
June 14, 2019
Study Completion
June 14, 2019
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share