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

October 10, 2022 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

Observational Study on Number and Outcome of Pregnancy in Childbearing Age Female Patients Treated With Chemotherapy for APL (Studies AIDA 0493, AIDA 2000)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
      • Ancona, Italy
        • Azienda Ospedaliera - Nuovo Ospedale "Torrette"
      • Bari, Italy, 70010
        • Unità Operativa Ematologia 1 - Università degli Studi di Bari
      • Bergamo, Italy
        • Ospedali Riuniti di Bergamo
      • Bologna, Italy, 40138
        • Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
      • Bolzano, Italy
        • Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
      • Brescia, Italy, 21125
        • Sezione di Ematologia e Trapianti Spedali Civili
      • Catanzaro, Italy
        • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
      • Cremona, Italy
        • Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
      • Ferrara, Italy, 44100
        • Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
      • Firenze, Italy
        • Policlinico di Careggi, Università delgi studi di Firenze
      • Genova, Italy
        • Clinica Ematologica - DiMI - Università degli Studi di Genova
      • Latina, Italy
        • Divisione di Ematologia Ospedale "Santa Maria Goretti"
      • Messina, 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"
      • Milano, Italy
        • U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
      • Milano, Italy
        • Ospedale Niguarda " Ca Granda"
      • Modena, Italy
        • Centro Oncologico Modenese - Dipartimento di Oncoematologia
      • Monza, Italy
        • N. Osp. divisione di Ematologia "S.Gerardo dei Tintori"
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
      • Napoli, Italy
        • Ospedale S. Gennaro ASL NA1
      • Palermo, Italy
        • Ospedali Riuniti "Villa Sofia-Cervello"
      • Palermo, Italy
        • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
      • Parma, Italy
        • Cattedra di Ematologia CTMO Università degli Studi di Parma
      • Perugia, Italy
        • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
      • Potenza, Italy
        • Istituto di Ematologia- Ospedale San Carlo
      • Reggio Calabria, Italy, 89100
        • Azienda Ospedaliera Bianchi Melacrino Morelli
      • Rionero in Vulture, Italy
        • Vulture U.O. di Ematologia - Centro Oncologico Basilicata
      • Roma, Italy
        • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
      • Roma, Italy, 00168
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • San Giovanni Rotondo, Italy
        • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Siena, Italy
        • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
      • Taranto, Italy
        • U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
      • Torino, Italy
        • SCDO Ematologia 2 AOU S.Giovanni Battista
      • Udine, Italy
        • Clinica Ematologica - Policlinico Universitario
      • Vicenza, Italy, 36100
        • Ospedale San Bortolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The patients enrolled in studies AIDA0493, AIDA2000 in CR .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of pregnancies
Time Frame: At 24 monhts from study entry
The primary objective is to describe pregnancies in female patients treated with AIDA0493, AIDA2000 studies.
At 24 monhts from study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's health
Time Frame: at 24 months from study entry
Children's health and follow-up data
at 24 months from study entry
Pregnancies evolution
Time Frame: At 24 months from study entry
Pregnancies evolution and outcome, children health and follow-up data according to AIDA0493 and AIDA2000 treatment strategies
At 24 months from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Giogina SPECCHIA, Pr., UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2012

Primary Completion (Actual)

June 14, 2019

Study Completion (Actual)

June 14, 2019

Study Registration Dates

First Submitted

November 11, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (Estimate)

November 16, 2011

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APL0511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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