Chronic Myeloid LeukemiaCML1012NCT01752062
Observational Study of Conception/Pregnancy in Adult Patients With CML Treated With Tyrosine Kinase Inhibitors
An observational study of Chronic Myeloid Leukemia and Pregnancy, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 52 sites in Italy.
Trial summary
The objective of this study is to acquire more information about what we are doing during pregnancy in CML patients, in order to possibly establish in the future a consensus on the management of patients receiving TKIs who wants to father a child or become/are pregnant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Pregnancy
- How many people
- 148 participants
- Where
- 52 sitesItaly
- Study dates
- 2 May 2013to Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (>18 years old) patients with a diagnosis of chronic myeloid leukemia (CML) who had been pregnant / had conceived while diagnosed with CML and treated with TKIs.
Who may be able to join
- Age > 18 years;
- Ph+/BCR-ABL+ CML in any phase of disease;
- Conception/pregnancy while diagnosed with CML
- Treatment with TKIs (before or after pregnancy);
- Signed written informed consent according to ICH/EU/GCP and national local laws.
Who cannot join
- Patient < 18 years
- Patients that suffer from any condition or illness that could prevent the patient to participate
Trial locations and contacts
52 sites in 1 country.
Paola Fazi, Dr. contact
Enrico Crea contact
52 sites in 1 country
Italy52 sites, 52 recruiting
- Recruiting
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona
Anna Rita Scortechini, Dr.
Anna Rita Scortechini, Dr.
- Not yet recruiting
S.G. Moscati Hospital
Avellino
Fausto Palmieri, Dr.
Fausto Palmieri, Dr.
- Recruiting
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari
Giorgina Specchia
Giorgina Specchia
- Recruiting
Divisione di Ematologia - Ospedali Riuniti Bergamo
Bergamo
Alessandro Rambaldi, Dr.
Alessandro Rambaldi, Dr.
- Recruiting
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna
Fausto Castagnetti, Dr.
Fausto Castagnetti, Dr.
- Recruiting
Spedali Civili - Azienda Ospedaliera - U.O. Ematologia
Brescia
Mariadele Capucci, Dr.
Mariadele Capucci, Dr.
- Recruiting
Divisione di Ematologia Ospedale A. Perrino
Brindisi
Angela Melpignano, Dr.
Mariella Girasoli, Dr.
- Recruiting
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Cagliari
Emilio Usala, Dr.
Emilio Usala, Dr.
- Recruiting
Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi
Catania
Ugo Consoli, Dr.
Ugo Consoli, Dr.
- Recruiting
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania
Fabio Stagno, Dr.
Fabio Stagno, Dr.
- Not yet recruiting
Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
Ferrara
Antonio Cuneo, Dr.
Antonio Cuneo, Dr.
- Recruiting
Policlinico di Careggi, Università Degli Studi Firenze
Florence
Alberto Bosi, Dr.
Alberto Bosi, Dr.
- Recruiting
Clinica Ematologica - DiMI - Università degli Studi di Genova
Genova
Ivana Pierri, Dr.
Ivana Pierri, Dr.
- Recruiting
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
Messina
Caterina Musolino, Dr.
Caterina Musolino, Dr.
- Recruiting
Ospedale Niguarda "Ca Granda"
Milan
Ester Pungolino, Dr.
Ester Pungolino, Dr.
- Recruiting
UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
Milan
Alessandra Iurlo, Dr.
Alessandra Iurlo, Dr.
- Recruiting
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori"
Monza
Carlo Gambacorti Passerini, Dr.
Carlo Gambacorti Passerini, Dr.
- Recruiting
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Napoli
Naples
Felicetto Ferrara, Dr.
Felicetto Ferrara, Dr.
- Recruiting
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Naples
Fabrizio Pane, Dr.
Fabrizio Pane, Dr.
- Recruiting
Ospedale San Gennaro - ASL Napoli 1
Naples
Lucia Mastrullo, Dr.
Lucia Mastrullo, Dr.
- Recruiting
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
Gianluca Gaidano, Dr.
Gianluca Gaidano, Dr.
- Recruiting
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 Prof. Giuseppe Saglio
Orbassano
Giovanna Rege, Dr.
Giovanna Rege, Dr.
- Recruiting
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
Palermo
Clementina Caracciolo, Dr.
Clementina Caracciolo, Dr.
- Not yet recruiting
Ospedale La Maddalena - Palermo
Palermo
Maurizio Musso, Dr.
Maurizio Musso, Dr.
- Recruiting
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo
Diamante Turri, Dr.
Diamante Turri, Dr.
- Recruiting
Div. di Ematologia IRCCS Policlinico S. Matteo
Pavia, 27100
Ester Orlandi, Dr.
Ester Orlandi, Dr.
- Not yet recruiting
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Pesaro
Giuseppe Visani
Giuseppe Visani, Dr.
- Recruiting
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara
Roberto Di Lorenzo, Dr.
Roberto Di Lorenzo, Dr.
- Recruiting
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
Piacenza
Elena Trabacchi, Dr.
Elena TRABACCHI, Dr.
- Recruiting
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
Pisa
Sara Galimberti, Dr.
Sara Galimberti, Dr.
- Recruiting
Ematologia - Ospedale San Carlo
Potenza
Michele Pizzuti, Pr.
Michele Pizzuti, Pr.
- Recruiting
Ospedale S. M. delle Croci
Ravenna, I-48100
Marzia Salvucci, Dr.
Marzia Salvucci, Dr.
- Recruiting
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria
Francesco Nobile, Dr.
Francesco Nobile, Dr.
- Recruiting
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia
Paolo Avanzini, Dr.
Paolo Avanzini, Dr.
- Recruiting
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma
Enrico Montefusco, Dr.
Enrico Montefusco, Dr.
- Recruiting
Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo
Roma
Leonardo Pacilli, Dr.
Leonardo Pacilli, Dr.
- Recruiting
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena- I.F.O. Istituto Nazionale Tumori Regina Elena Roma
Roma
Atelda Dr. Romano
Atelda Romano, Dr.
- Recruiting
U.O.C. Ematologia - Ospedale S.Eugenio
Roma
Elisabetta Abruzzese, Dr.
Elisabetta Abruzzese, Dr.
- Recruiting
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
Simona Sica
Simona Sica, Dr.
- Recruiting
UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
Roma
Giuliana Alimena, Dr.
Giuliana Alimena, Dr.
- Not yet recruiting
Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannetasio - Azienda ASL 3 Rossano (CS)
Rossano, Cosenza
Francesco Iuliano, Dr.
Francesco Iuliano, Dr.
- Recruiting
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Nicola Cascavilla, Dr.
Nicola Cascavilla, Dr.
- Recruiting
Ematologia - Dipartimento di Medicina Clinica e Sperimentale
Sassari
Claudio Fozza
Claudio Fozza
- Recruiting
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena
Monica Bocchia, Dr.
Monica Bocchia, Dr.
- Not yet recruiting
U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
Taranto
Alessandro Maggi, Dr.
Alessandro Maggi, Dr.
- Not yet recruiting
Azienda ospedaliera S. Maria di Terni
Terni
Anna Maria Liberati, Dr.
Anna Maria Liberati, Dr.
- Recruiting
SCDO Ematologia 2 AOU S. Giovanni Battista
Torino
Patrizia Pregno, Dr.
Patrizia Pregno, Dr.
- Not yet recruiting
Sezione di Ematologia - Med.II Div. Presidio Ospedaliero S. Chiara di Trento
Trento
Paolo Vivaldi, Dr.
Paolo Vivaldi, Dr.
- Recruiting
Azienda U.L.S.S.9 - U.O. di Ematologia
Treviso
Filippo Gherlinzoni, Dr.
Filippo Gherlinzoni, Dr.
- Recruiting
Policlinico Universitario - Clinica Ematologia
Udine, 33100
Mario Tiribelli, Dr
Mario Tiribelli, Dr.
- Not yet recruiting
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona
Massimiliano Bonifacio, Dr.
Massimiliano Bonifacio, Dr.
- Recruiting
ULSS N.6 Osp. S. Bortolo
Vicenza
Anna D'Emilio, Dr.
Anna D'Emilio, Dr.
About this study
Official title: Observational Study of Conception/Pregnancy in Adult Patients With Chronic Myeloid Leukemia (CML) Treated With Tyrosine Kinase Inhibitors
The objective of this study is to acquire more information about what we are doing during pregnancy in CML patients, in order to possibly establish in the future a consensus on the management of patients receiving TKIs who wants to father a child or become/are pregnant.
Read the detailed description
The management of patients with chronic myeloid leukemia (CML) during pregnancy is a matter of continued debate. The introduction of the TKIs in clinical practice has dramatically changed the prognosis of CML. Patients diagnosed in chronic phase can reasonably expect many years of excellent disease control and good quality of life. Thus, the need to address issues related to fertility and pregnancy have arisen. Physicians are frequently being asked for advice regarding the need for, and or the appropriateness of, stopping treatment in order to conceive. The management of fertility begins at diagnosis. This means that immediate and future treatments should be considered at the very beginning. Therefore, the maintenance of fertility should be taken into account since diagnosis. Imatinib is not genotoxic but might lead to a decrease in sperm counts. Nevertheless, Imatinib is teratogenic in rats when given during organogenesis at doses higher than 100 mg/kg, approximately equivalent to 800 mg/day in men. Until now, approximately 60 pregnancies were reported in partners of men on Imatinib. No suggestions of any problems in conception, pregnancy, delivery or any increase in congenital abnormalities were reported. Regarding women, 204 patients were exposed to Imatinib, and 180 were reported in literature (76, 77). Of 180 women exposed to imatinib during pregnancy, outcome data are available for 125 (69%). Of those with known outcomes, 50% delivered normal infants and 28% underwent elective terminations, 3 following the identification of abnormalities. There were a total of 12 infants in whom abnormalities were identified, 3 of which had strikingly similar complex malformations that are clearly a cause for concern. It appears that although most pregnancies exposed to imatinib are likely to have a successful outcome, there remains a risk that exposure may result in serious fetal malformations. Although numbers are small there has been a disturbing cluster of rare congenital malformations such that imatinib cannot be safely recommended, particularly during the period of organogenesis. Last but not least, it has recently been reported a poor outcome after reintroduction of Imatinib in patients who interrupt therapy for pregnancy without having achieved an optimal response (78), introducing another variable in the management of women pregnant while receiving Imatinib. Only few data are available about the use of second generation TKIs, Nilotinib and Dasatinib, during pregnancy. Dasatinib is not mutagenic in rats (in vitro and in vivo tests), but is clastogenic in CHO cells. It does not seem to have such effect on fertility of male and female rats. However, it gives skeletal alterations in rats and rabbits and has embryolethality in rats if administered during pregnancies. Eleven pregnancies were reported while in dasatinib: 5 patients delivered normal infants, while 3 elective termination and 2 spontaneous abortion were reported. On the other hand, 9 male patient conceived during dasatinib: 8 normal infants were delivered, and 1 case was ongoing at the time of the report. Nilotinib is not mutagenic in rats. It does not have any effect on fertility in male and female rats. When administered during pregnancy, there is no evidence of teratogenicity but it is embryo and foetotoxic in the rat and in the rabbit. Only sporadic cases of patients who had been pregnant/had conceived during Nilotinib have been reported, and no speculation should be made from these data. In summary, there are virtually no data regarding II generation TKIs, that must be discontinued by women wishing to become pregnant. Several questions still remains unanswered regarding the management of patients receiving TKIs who want to conceive, or who have been exposed to TKI during pregnancy/conception.
- Conditions
- Chronic Myeloid Leukemia, Pregnancy
- Keywords
- Chronic Myeloid Leukemia, CML, Pregnancy
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of normal birth, elective termination and spontaneous abortion
Pregnancy outcome: it will be calculated in terms of normal birth, elective termination, spontaneous abortion
Measured: At 3 years from study entry
Number of patients with major molecular remission loss
Cumulative Incidence of MMR loss: it will be calculated from the date of achievement of MMR using the cumulative incidence method, where death will be considered as competing risk. Patients still alive, in first MMR, will be censored at the moment of last follow-up.
Measured: At 3 years from study entry
Number of patients with disease progression
Cumulative Incidence of Disease Progression: it will be calculated from the date of diagnosis using the cumulative incidence method, where death without signs of disease progression will be considered as competing risk. Patients still alive, without a date of progression, will be censored at the moment of last follow-up.
Measured: At 3 years from study entry.
Number of patients with CCgR loss
Cumulative Incidence of CCgRloss: it will be calculated from the date of achievement of CCgR using the cumulative incidence method, where death in CCgR will be considered as competing risk. Patients still alive, in first CCgR, will be censored at the moment of last follow-up.
Measured: At 3 years from study entry
Secondary outcomes (7)
Number of male and female patients conceiving during treatment
Proportion of male and female patients conceiving during the treatment with TKI
Measured: At 3 years from study entry
Number of spontaneous abortion
Proportion of spontaneous abortion
Measured: At 3 years from study entry
Number of of foetal abnormalities
Proportion of foetal abnormalities: it will be calculated with respect to the study population and with respect to normal population.
Measured: At 3 years from study entry
Number of patients surviving
Overall Survival (OS): it will be calculated from the date of CML diagnosis until date of death (whatever the cause). Patients still alive will be censored at the moment of last follow-up.
Measured: At 3 years from study entry
Number of patients alive with no disease progression
Progression Free Survival (PFS): it will be calculated from the date of CML diagnosis until the date of first progression to A-B phase or until death (whatever the cause), whichever occurs first. Patients still alive, without a date of progression, will be censored at the moment of last follow-up.
Measured: At 3 years from study entry
Number of patients with molecular response.
Duration of CCgR/ Molecular response (MR): it will be calculated from the date of achievement of CCgR, MR until first date of CCgR loss or until death (whatever the cause), whichever occurs first. Patients still alive, in first CCgR/MR, will be censored at the moment of last follow-up.
Measured: At 3 years from study entry
Number of patients with major molecular remission
Evaluation of Major Molecular Remission (MMR)
Measured: At 3 years 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 posted18 Dec 2012 (estimated)
- Study start2 May 2013
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid 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
- Prospective
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabetta Abruzzese, Principal investigator, Hematology, S. Eugenio Hospital, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752062
- Sponsor's protocol ID
- CML1012
- Acronym
- CML1012
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2012
- Last updated
- 5 Jan 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 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Conception/Pregnancy in Adult Patients With Chronic Myeloid Leukemia (CML) Treated With Tyrosine Kinase Inhibitors
- ClinicalTrials.gov ID
- NCT01752062
- Acronym / sponsor ID
- CML1012 / CML1012
- Conditions
- Chronic Myeloid Leukemia, Pregnancy
- Keywords
- Chronic Myeloid Leukemia, CML, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 2 May 2013 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Dec 2012 (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 objective of this study is to acquire more information about what we are doing during pregnancy in CML patients, in order to possibly establish in the future a consensus on the management of patients receiving TKIs who wants to father a child or become/are pregnant.
Detailed description
The management of patients with chronic myeloid leukemia (CML) during pregnancy is a matter of continued debate. The introduction of the TKIs in clinical practice has dramatically changed the prognosis of CML. Patients diagnosed in chronic phase can reasonably expect many years of excellent disease control and good quality of life. Thus, the need to address issues related to fertility and pregnancy have arisen. Physicians are frequently being asked for advice regarding the need for, and or the appropriateness of, stopping treatment in order to conceive. The management of fertility begins at diagnosis. This means that immediate and future treatments should be considered at the very beginning. Therefore, the maintenance of fertility should be taken into account since diagnosis. Imatinib is not genotoxic but might lead to a decrease in sperm counts. Nevertheless, Imatinib is teratogenic in rats when given during organogenesis at doses higher than 100 mg/kg, approximately equivalent to 800 mg/day in men. Until now, approximately 60 pregnancies were reported in partners of men on Imatinib. No suggestions of any problems in conception, pregnancy, delivery or any increase in congenital abnormalities were reported. Regarding women, 204 patients were exposed to Imatinib, and 180 were reported in literature (76, 77). Of 180 women exposed to imatinib during pregnancy, outcome data are available for 125 (69%). Of those with known outcomes, 50% delivered normal infants and 28% underwent elective terminations, 3 following the identification of abnormalities. There were a total of 12 infants in whom abnormalities were identified, 3 of which had strikingly similar complex malformations that are clearly a cause for concern. It appears that although most pregnancies exposed to imatinib are likely to have a successful outcome, there remains a risk that exposure may result in serious fetal malformations. Although numbers are small there has been a disturbing cluster of rare congenital malformations such that imatinib cannot be safely recommended, particularly during the period of organogenesis. Last but not least, it has recently been reported a poor outcome after reintroduction of Imatinib in patients who interrupt therapy for pregnancy without having achieved an optimal response (78), introducing another variable in the management of women pregnant while receiving Imatinib. Only few data are available about the use of second generation TKIs, Nilotinib and Dasatinib, during pregnancy. Dasatinib is not mutagenic in rats (in vitro and in vivo tests), but is clastogenic in CHO cells. It does not seem to have such effect on fertility of male and female rats. However, it gives skeletal alterations in rats and rabbits and has embryolethality in rats if administered during pregnancies. Eleven pregnancies were reported while in dasatinib: 5 patients delivered normal infants, while 3 elective termination and 2 spontaneous abortion were reported. On the other hand, 9 male patient conceived during dasatinib: 8 normal infants were delivered, and 1 case was ongoing at the time of the report. Nilotinib is not mutagenic in rats. It does not have any effect on fertility in male and female rats. When administered during pregnancy, there is no evidence of teratogenicity but it is embryo and foetotoxic in the rat and in the rabbit. Only sporadic cases of patients who had been pregnant/had conceived during Nilotinib have been reported, and no speculation should be made from these data. In summary, there are virtually no data regarding II generation TKIs, that must be discontinued by women wishing to become pregnant. Several questions still remains unanswered regarding the management of patients receiving TKIs who want to conceive, or who have been exposed to TKI during pregnancy/conception.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (>18 years old) patients with a diagnosis of chronic myeloid leukemia (CML) who had been pregnant / had conceived while diagnosed with CML and treated with TKIs.
Key inclusion criteria (5 listed)
- Age > 18 years;
- Ph+/BCR-ABL+ CML in any phase of disease;
- Conception/pregnancy while diagnosed with CML
- Treatment with TKIs (before or after pregnancy);
- Signed written informed consent according to ICH/EU/GCP and national local laws.
Key exclusion criteria (2 listed)
- Patient < 18 years
- Patients that suffer from any condition or illness that could prevent the patient to participate
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
Number of normal birth, elective termination and spontaneous abortion
Time frame: At 3 years from study entry
Pregnancy outcome: it will be calculated in terms of normal birth, elective termination, spontaneous abortion
Number of patients with major molecular remission loss
Time frame: At 3 years from study entry
Cumulative Incidence of MMR loss: it will be calculated from the date of achievement of MMR using the cumulative incidence method, where death will be considered as competing risk. Patients still alive, in first MMR, will be censored at the moment of last follow-up.
Number of patients with disease progression
Time frame: At 3 years from study entry.
Cumulative Incidence of Disease Progression: it will be calculated from the date of diagnosis using the cumulative incidence method, where death without signs of disease progression will be considered as competing risk. Patients still alive, without a date of progression, will be censored at the moment of last follow-up.
Number of patients with CCgR loss
Time frame: At 3 years from study entry
Cumulative Incidence of CCgRloss: it will be calculated from the date of achievement of CCgR using the cumulative incidence method, where death in CCgR will be considered as competing risk. Patients still alive, in first CCgR, will be censored at the moment of last follow-up.
7 secondary outcomes
Number of male and female patients conceiving during treatment
Time frame: At 3 years from study entry
Number of spontaneous abortion
Time frame: At 3 years from study entry
Number of of foetal abnormalities
Time frame: At 3 years from study entry
Number of patients surviving
Time frame: At 3 years from study entry
Number of patients alive with no disease progression
Time frame: At 3 years from study entry
Number of patients with molecular response.
Time frame: At 3 years from study entry
Number of patients with major molecular remission
Time frame: At 3 years from study entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- GIMEMA FoundationLink 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.
Paola Fazi, Dr. contact
Enrico Crea contact
Elisabetta Abruzzese principal investigator
Hematology, S. Eugenio Hospital, Rome
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia and Pregnancy, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 52 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi, Dr. (p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of normal birth, elective termination and spontaneous abortion (time frame: At 3 years from study entry). The study lists 4 primary outcomes in all. 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 5 Jan 2022.