Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy (APL0511)

This study is currently recruiting participants.
Verified November 2013 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01472107
First received: November 11, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition
Acute Promyelocytic Leukemia Female Patients
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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)

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • Description of pregnancies [ Time Frame: At 24 monhts from study entry ] [ Designated as safety issue: No ]
    The primary objective is to describe pregnancies in female patients treated with AIDA0493, AIDA2000 studies.


Secondary Outcome Measures:
  • Children's health [ Time Frame: at 24 months from study entry ] [ Designated as safety issue: No ]
    Children's health and follow-up data

  • Pregnancies evolution [ Time Frame: At 24 months from study entry ] [ Designated as safety issue: No ]
    Pregnancies evolution and outcome, children health and follow-up data according to AIDA0493 and AIDA2000 treatment strategies


Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patients enrolled in studies AIDA0493, AIDA2000 in CR .

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472107

Contacts
Contact: Paola FAZI, Dr. p.fazi@gimema.it
Contact: Enrico CREA e.crea@gimema.it

Locations
Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo Recruiting
Alessandria, Italy
Contact: Lorella De Paoli, Dr.         
Principal Investigator: Lorella De Paoli, Dr.         
Sub-Investigator: Flavia Salvi, Dr.         
Azienda Ospedaliera - Nuovo Ospedale "Torrette" Active, not recruiting
Ancona, Italy
Unità Operativa Ematologia 1 - Università degli Studi di Bari Recruiting
Bari, Italy, 70010
Contact: Giorgina SPECCHIA, Pr.         
Principal Investigator: Giorgina SPECCHIA, Pr.         
Sub-Investigator: Paola CARLUCCIO, Dr.         
Ospedali Riuniti di Bergamo Active, not recruiting
Bergamo, Italy
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi Active, not recruiting
Bologna, Italy, 40138
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO Not yet recruiting
Bolzano, Italy
Contact: Vincenzo Cassibba, Dr.         
Principal Investigator: Vincenzo Cassibba, Dr.         
Sub-Investigator: Irene Cavattoni, Dr.         
Sezione di Ematologia e Trapianti Spedali Civili Active, not recruiting
Brescia, Italy, 21125
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia Not yet recruiting
Catanzaro, Italy
Contact: Stefano Molica, Dr.         
Principal Investigator: Stefano Molica, Dr.         
Sub-Investigator: Maria Grazia Kropp, Dr.         
Sezione di Ematologia C.T.M.O. Istituti Ospitalieri Not yet recruiting
Cremona, Italy
Contact: Francesco Lanza, Pr.         
Principal Investigator: Francesco Lanza, Pr.         
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna Recruiting
Ferrara, Italy, 44100
Contact: Antonio CUNEO, Pr.         
Principal Investigator: Antonio CUNEO, Pr.         
Sub-Investigator: Maria CICCONE, Dr.         
Policlinico di Careggi, Università delgi studi di Firenze Active, not recruiting
Firenze, Italy
Clinica Ematologica - DiMI - Università degli Studi di Genova Not yet recruiting
Genova, Italy
Contact: Marco Gobbi, Pr.         
Principal Investigator: Marco Gobbi, Pr.         
Sub-Investigator: Ivana Pierri, Dr.         
Divisione di Ematologia Ospedale "Santa Maria Goretti" Active, not recruiting
Latina, Italy
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina Active, not recruiting
Messina, Italy
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" Active, not recruiting
Messina, Italy
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele Recruiting
Milano, Italy
Contact: Elena Guggiari, Dr.         
Principal Investigator: Elena Guggiari, Dr.         
Ospedale Niguarda " Ca Granda" Active, not recruiting
Milano, Italy
Centro Oncologico Modenese - Dipartimento di Oncoematologia Recruiting
Modena, Italy
Contact: Mario Luppi, Dr.         
Principal Investigator: Mario Luppi, Dr.         
Sub-Investigator: Monica Morselli, Dr.         
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori" Active, not recruiting
Monza, Italy
Ospedale S. Gennaro ASL NA1 Recruiting
Napoli, Italy
Contact: Lucia MASTRULLO, Dr.         
Principal Investigator: Lucia MASTRULLO, Pr.         
Sub-Investigator: Maria Rosaria VILLA, Dr.         
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia Not yet recruiting
Napoli, Italy
Contact: Fabrizio Pane, Pr.         
Principal Investigator: Fabrizio Pane, Pr.         
Sub-Investigator: Giuseppe Cerciello, Dr.         
Ospedali Riuniti "Villa Sofia-Cervello" Active, not recruiting
Palermo, Italy
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone" Not yet recruiting
Palermo, Italy
Contact: Maria Enza Mitra, Dr.         
Principal Investigator: Maria Enza Mitra, Dr.         
Cattedra di Ematologia CTMO Università degli Studi di Parma Not yet recruiting
Parma, Italy
Contact: Cecilia CARAMATTI, Dr.         
Principal Investigator: Cecilia CARAMATTI, Dr.         
Sub-Investigator: Elena ROSETTI, Dr.         
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della MIsericordia Active, not recruiting
Perugia, Italy
Istituto di Ematologia- Ospedale San Carlo Not yet recruiting
Potenza, Italy
Contact: Michele PIZZUTI         
Principal Investigator: Michele PIZZUTI, Pr.         
Azienda Ospedaliera Bianchi Melacrino Morelli Not yet recruiting
Reggio Calabria, Italy, 89100
Contact: Francesco NOBILE, Pr.         
Principal Investigator: Francesco Nobile, Pr.         
Sub-Investigator: Caterina Alati, Dr.         
Vulture U.O. di Ematologia - Centro Oncologico Basilicata Active, not recruiting
Rionero in Vulture, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Recruiting
Roma, Italy, 00168
Contact: Simona SICA, Dr.         
Principal Investigator: Simona SICA, Dr.         
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza Active, not recruiting
S. G. Rotondo, Italy
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte" Recruiting
Siena, Italy
Contact: Monica Bocchia, Pr.         
Principal Investigator: Monica Bocchia, Pr.         
Sub-Investigator: Laura Aprile, Dr.         
U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati Not yet recruiting
Taranto, Italy
Contact: Emilio Iannitto, Dr.         
Principal Investigator: Emilio Iannitto, Dr.         
Sub-Investigator: Maria Rosaria Specchia, Dr.         
SCDO Ematologia 2 AOU S.Giovanni Battista Active, not recruiting
Torino, Italy
Clinica Ematologica - Policlinico Universitario Recruiting
Udine, Italy
Contact: Anna Candoni, Dr.         
Principal Investigator: Anna Candoni, Dr.         
Sub-Investigator: Erica Simeone, Dr.         
Ospedale San Bortolo Recruiting
Vicenza, Italy, 36100
Contact: Eros DI BONA, Pr.       dibona@hemato.ven.it   
Principal Investigator: Eros DI BONA, Pr.         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Giogina SPECCHIA, Pr. UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
  More Information

Additional Information:
No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01472107     History of Changes
Other Study ID Numbers: APL0511
Study First Received: November 11, 2011
Last Updated: November 26, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Pregnancy
APL female patients

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid

ClinicalTrials.gov processed this record on April 15, 2014