Observational Study of Conception/Pregnancy in Adult Patients With CML Treated With Tyrosine Kinase Inhibitors

NCT01752062 | Unknown

• 1 other identifier: CML1012
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 52

Brief 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.

Conditions

Chronic Myeloid Leukemia; Pregnancy

Keywords

Chronic Myeloid Leukemia; CML; Pregnancy

Outcome Measures

Primary Outcomes (4)

• Number of normal birth, elective termination and spontaneous abortion

  Pregnancy outcome: it will be calculated in terms of normal birth, elective termination, spontaneous abortion

  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.

  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.

  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.

  At 3 years from study entry

Secondary Outcomes (7)

• Number of male and female patients conceiving during treatment

  At 3 years from study entry

• Number of spontaneous abortion

  At 3 years from study entry

• Number of of foetal abnormalities

  At 3 years from study entry

• Number of patients surviving

  At 3 years from study entry

• Number of patients alive with no disease progression

  At 3 years from study entry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patient \< 18 years
• Patients that suffer from any condition or illness that could prevent the patient to participate

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (52)

Unità Operativa di Oncologia - Presidio Ospedaliero N. Giannetasio - Azienda ASL 3 Rossano (CS)

Rossano, Cosenza, Italy

NOT YET RECRUITING

Azienda Ospedaliera - Nuovo Ospedale "Torrette"

Ancona, Italy

RECRUITING

S.G. Moscati Hospital

Avellino, Italy

NOT YET RECRUITING

UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro

Bari, Italy

RECRUITING

Divisione di Ematologia - Ospedali Riuniti Bergamo

Bergamo, Italy

RECRUITING

Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

Bologna, Italy

RECRUITING

Spedali Civili - Azienda Ospedaliera - U.O. Ematologia

Brescia, Italy

RECRUITING

Divisione di Ematologia Ospedale A. Perrino

Brindisi, Italy

RECRUITING

ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

Cagliari, Italy

RECRUITING

Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi

Catania, Italy

RECRUITING

Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

Catania, Italy

RECRUITING

Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna

Ferrara, Italy

NOT YET RECRUITING

Policlinico di Careggi, Università Degli Studi Firenze

Florence, Italy

RECRUITING

Clinica Ematologica - DiMI - Università degli Studi di Genova

Genova, Italy

RECRUITING

Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina

Messina, Italy

RECRUITING

Ospedale Niguarda "Ca Granda"

Milan, Italy

RECRUITING

UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

N. Osp. divisione di Ematologia "S.Gerardo dei Tintori"

Monza, Italy

RECRUITING

Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Napoli

Napoli, Italy

RECRUITING

Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

Napoli, Italy

RECRUITING

Ospedale San Gennaro - ASL Napoli 1

Napoli, Italy

RECRUITING

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, Italy

RECRUITING

Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2 Prof. Giuseppe Saglio

Orbassano, Italy

RECRUITING

Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"

Palermo, Italy

RECRUITING

Ospedale La Maddalena - Palermo

Palermo, Italy

NOT YET RECRUITING

Ospedali Riuniti "Villa Sofia-Cervello"

Palermo, Italy

RECRUITING

Div. di Ematologia IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

RECRUITING

Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore

Pesaro, Italy

NOT YET RECRUITING

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, Italy

RECRUITING

Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza

Piacenza, Italy

RECRUITING

Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia

Pisa, Italy

RECRUITING

Ematologia - Ospedale San Carlo

Potenza, Italy

RECRUITING

Ospedale S. M. delle Croci

Ravenna, I-48100, Italy

RECRUITING

Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

Reggio Calabria, Italy

RECRUITING

Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

Reggio Emilia, Italy

RECRUITING

Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

Roma, Italy

RECRUITING

Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo

Roma, Italy

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, Italy

RECRUITING

U.O.C. Ematologia - Ospedale S.Eugenio

Roma, Italy

RECRUITING

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, Italy

RECRUITING

UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"

Roma, Italy

RECRUITING

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

RECRUITING

Ematologia - Dipartimento di Medicina Clinica e Sperimentale

Sassari, Italy

RECRUITING

U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"

Siena, Italy

RECRUITING

U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati

Taranto, Italy

NOT YET RECRUITING

Azienda ospedaliera S. Maria di Terni

Terni, Italy

NOT YET RECRUITING

SCDO Ematologia 2 AOU S. Giovanni Battista

Torino, Italy

RECRUITING

Sezione di Ematologia - Med.II Div. Presidio Ospedaliero S. Chiara di Trento

Trento, Italy

NOT YET RECRUITING

Azienda U.L.S.S.9 - U.O. di Ematologia

Treviso, Italy

RECRUITING

Policlinico Universitario - Clinica Ematologia

Udine, 33100, Italy

RECRUITING

Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

Verona, Italy

NOT YET RECRUITING

ULSS N.6 Osp. S. Bortolo

Vicenza, Italy

RECRUITING

Related Links

• GIMEMA Foundation

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisabetta Abruzzese

  Hematology, S. Eugenio Hospital, Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi, Dr.

CONTACT

p.fazi@gimema.it

Enrico Crea

CONTACT

e.crea@gimema.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 18, 2012
• Study Start: May 2, 2013
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (52)