Acute Promyelocytic LeukemiaAPL0511NCT01472107
Study on Number and Outcome of Pregnancy in Acute Promielocitic Leukaemia (APL) Patients Treated With Chemotherapy
An observational study of Acute Promyelocytic Leukemia and Pregnancy, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 36 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Acute Promyelocytic Leukemia, Pregnancy
- How many people
- 69 participants
- Where
- 36 sitesItaly
- Study dates
- 7 Mar 2012to 14 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The patients enrolled in studies AIDA0493, AIDA2000 in CR .
Who may be able to join
- 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
Who cannot join
- Patients aged < 18 and > 50 years;
- Patients receiving chemotherapy;
- Concomitant psychiatric disorder that would interfere or prevent the subject from participating in the study.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Italy36 sites
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona
Unità Operativa Ematologia 1 - Università degli Studi di Bari
Bari, 70010
Ospedali Riuniti di Bergamo
Bergamo
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
Bologna, 40138
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
Bolzano
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, 21125
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro
Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
Cremona
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, 44100
Policlinico di Careggi, Università delgi studi di Firenze
Florence
Clinica Ematologica - DiMI - Università degli Studi di Genova
Genova
Divisione di Ematologia Ospedale "Santa Maria Goretti"
Latina
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Messina
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina
Ospedale Niguarda " Ca Granda"
Milan
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele
Milan
Centro Oncologico Modenese - Dipartimento di Oncoematologia
Modena
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori"
Monza
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Naples
Ospedale S. Gennaro ASL NA1
Naples
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
Palermo
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della MIsericordia
Perugia
Istituto di Ematologia- Ospedale San Carlo
Potenza
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, 89100
Vulture U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, 00168
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena
U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
Taranto
SCDO Ematologia 2 AOU S.Giovanni Battista
Torino
Clinica Ematologica - Policlinico Universitario
Udine
Ospedale San Bortolo
Vicenza, 36100
About this study
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)
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.
Read the 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.
- Conditions
- Acute Promyelocytic Leukemia, Pregnancy
- Keywords
- Pregnancy, APL female patients
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of pregnancies
The primary objective is to describe pregnancies in female patients treated with AIDA0493, AIDA2000 studies.
Measured: At 24 monhts from study entry
Secondary outcomes (2)
Children's health
Children's health and follow-up data
Measured: at 24 months from study entry
Pregnancies evolution
Pregnancies evolution and outcome, children health and follow-up data according to AIDA0493 and AIDA2000 treatment strategies
Measured: At 24 months from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study start7 Mar 2012
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Promyelocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giogina SPECCHIA, Pr., Principal investigator, UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472107
- Sponsor's protocol ID
- APL0511
- Acronym
- APL0511
- Status last verified
- Oct 2022
- First submitted
- 11 Nov 2011
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01472107
- Acronym / sponsor ID
- APL0511 / APL0511
- Conditions
- Acute Promyelocytic Leukemia, Pregnancy
- Keywords
- Pregnancy, APL female patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 7 Mar 2012 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The patients enrolled in studies AIDA0493, AIDA2000 in CR .
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients aged < 18 and > 50 years;
- Patients receiving chemotherapy;
- Concomitant psychiatric disorder that would interfere or prevent the subject from participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Children's health
Time frame: at 24 months from study entry
Pregnancies evolution
Time frame: At 24 months from study entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- GIMEMA Foundation WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giogina SPECCHIA, Pr. principal investigator
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Promyelocytic Leukemia and Pregnancy, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 36 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of pregnancies (time frame: At 24 monhts from study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.