Front-line Treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) With Dasatinib
CML1113
2 other identifiers
observational
147
1 country
37
Brief Summary
The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored, prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with dasatinib. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early phases. The primary objective of the study is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2013
CompletedFirst Posted
Study publicly available on registry
January 7, 2013
CompletedStudy Start
First participant enrolled
January 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 5, 2022
August 1, 2021
4.8 years
January 3, 2013
January 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of dasatinib permanent discontinuing patients.
The cumulative rate of dasatinib permanent discontinuation by 2 years.
After 2 years from study entry.
Secondary Outcomes (18)
Number of dasatinib permanent discontinuing patients.
After 5 years from study entry.
Number of confirmed MR4 and MR4.5.
After 2 years from study entry.
Number of confirmed MR4 and MR4.5.
After 60 months from study entry.
Number of stable MR4 and MR4.5 and characteristics.
After 60 months from study entry.
Number of Complete Cytogenetic Responses (CCgR)
After one year from study entry.
- +13 more secondary outcomes
Study Arms (1)
CML patients
Interventions
Treatment decision is at the discretion of the investigator and must not be made on the basis of this observational study. Patients should have their treatment initiated in accordance with the summary of product characteristics.
Eligibility Criteria
This is a multicentre, observational, prospective study of newly diagnosed chronic phase CML patients treated frontline with Dasatinib 100 mg QD.
You may qualify if:
- Cytogenetic and/or molecular confirmed diagnosis of Ph+ and/or BCR-ABL+ CML; Age 18 years;
- Early chronic phase, less than 6 months from diagnosis. Prior treatment with Hydroxyurea or Anagrelide is allowed;
- Signed written informed consent according to ICH/EU/GCP and national local laws prior to any study procedures.
You may not qualify if:
- Prior treatment with any protein tyrosin-kinase inhibitor (TKI) or interferon;
- Recommendations and precautions before allocating a new CML case to dasatinib are fully described in the prescribing information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Centro Oncologico Basilicata
Rionero in Vulture, Potenza, Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, Italy
U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno
Ascoli Piceno, Italy
Az.Ospedaliera S.G.Moscati
Avellino, Italy
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari, Italy
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
Bologna, 40138, Italy
U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
Campobasso, Italy
US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo
Castelfranco Veneto, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Ferrara, Italy
Azienda Ospedaliera di Firenze
Florence, 50011, Italy
Centro Aziendale di Ematologia ASL N. 6
Livorno, 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"
Messina, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Milan, Italy
Ospedale San Gennaro - ASL Napoli 1
Napoli, Italy
zienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, Italy
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
Orbassano, Italy
La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello
Palermo, Italy
zienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Palermo, Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
Piacenza, Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma, Italy
Complesso Ospedaliero S. Giovanni Addolorata
Roma, Italy
Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo
Roma, Italy
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
Roma, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
Roma, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
Rotondo Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
Siena, Italy
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino, Italy
Clinica Ematologica - Policlinico Universitario
Udine, Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michele Baccarani, Pr.
Orsola Malpighi, Bologna
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2013
First Posted
January 7, 2013
Study Start
January 28, 2014
Primary Completion
December 2, 2018
Study Completion
December 1, 2022
Last Updated
January 5, 2022
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share