Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib
CML0609
Observational Study in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia (CML) Treated With Nilotinib: Follow-up of the Italian Patients. GIMEMA Study CML0609
1 other identifier
observational
19
1 country
33
Brief Summary
The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollment will include all patients who started Nilotinib between January 2005 and December 2012. Patients will be followed for 4 years since treatment start. After this time, survival data, disease status and treatment will be recorded at 6-months-interval. This study will help the definition of guidelines for a proper management of Nilotinib in any-phase CML patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2012
Longer than P75 for all trials
33 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
November 11, 2011
CompletedFirst Posted
Study publicly available on registry
November 21, 2011
CompletedStudy Start
First participant enrolled
September 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2016
CompletedOctober 25, 2022
October 1, 2022
4.2 years
November 11, 2011
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
At one year from study entry
Secondary Outcomes (8)
Rate of complete haematologic remission t
At one year from study entry
Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death
At one year from study entry
Event Free Survival (EFS)
At one year from study entry
Progression Free Survival (PFS)
At one year from study entry
Rate of point mutations before or after Nilotinib treatment
At one year from study entry
- +3 more secondary outcomes
Study Arms (1)
Study cohort group
Adult patients with Imatinib resistant (failure + suboptimal) or intolerant chronic myeloid leukaemia in all phases, who started treatment with Nilotinib between January 2005 and December 2012 in Italy. Adult pts treated with Nilotinib as second line therapy after Dasatinib.
Interventions
Eligibility Criteria
The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollement will include all patients who started Nilotinib between January 2005 and December 2012.
You may qualify if:
- Adult patients with Imatinib resistant (failure + suboptimal) or intolerant chronic myeloid leukaemia in all phases, who started treatment with Nilotinib between January 2005 and December 2012 in Italy.
- Adult pts treated with Nilotinib as second line therapy after Dasatinib.
You may not qualify if:
- Patients less than 18 year old.
- Use of Nilotinib as first line treatment.
- Patients treated with Nilotinib before 2005.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Centro Oncologico Basilicata
Rionero in Vulture, Potenza, Italy
Ospedale
Alessandria, Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
S.G. Moscati Hospital
Avellino, Italy
Ospedale
Bari, Italy
Ospedale
Bologna, Italy
Azienda Spedali Civili
Brescia, 25100, Italy
Ospedale Ferrarotto
Catania, Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, 44100, Italy
Policlinico di Careggi, Università delgi studi di Firenze
Florence, Italy
Clinica Ematologica - Università degli Studi
Genova, Italy
Università degli Studi
Genova, Italy
Università di Genova
Genova, Italy
ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia
Lecce, 73100, Italy
A.O. Universitaria Policlinico Martina di Messina
Messina, Italy
U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele
Milan, 20132, Italy
Federico II
Napoli, Italy
Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10
Orbassano, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Ospedale Cervello
Palermo, 90146, Italy
Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
Palermo, Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna, Italy
Ospedale
Reggio Calabria, Italy
Ospedale
Rimini, Italy
U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture, Italy
Ematologia - Sapienza Università di Roma
Roma, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, 00168, Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena, 53100, Italy
Ospedale
Taranto, Italy
SCDO Ematologia 2 AOU S. Giovanni Battista
Torino, Italy
Policlinico Universitario - Clinica Ematologia
Udine, 33100, Italy
Policlinico G. B. Rossi - Borgo Roma
Verona, 37134, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe SAGLIO, Pr.
Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2011
First Posted
November 21, 2011
Study Start
September 13, 2012
Primary Completion
November 24, 2016
Study Completion
November 24, 2016
Last Updated
October 25, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share