Clinical trial NCT01475110: Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukaemia
Keywords: Imatinib
Chronic Myeloid Leukaemia
Nilotinib
Adult patients
Imatinib resistant
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: Follow-up is required until the end of treatment for the purposes of the study for all patients by standard hematologic, cytogenetic and molecular criteria. This study will not contemplate any additional expense beyond what is expected for a regular follow-up, according to the international guidelines for CML.

Sample Size: target accrual was not defined, all eligible patients observed between January 2005 and December 2012 will be included.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients less than 18 year old.
* Use of Nilotinib as first line treatment.
* Patients treated with Nilotinib before 2005.

Primary outcomes:
measure: Overall Survival
timeFrame: At one year from study entry
Secondary outcomes:
measure: Rate of complete haematologic remission t
timeFrame: At one year from study entry
measure: Nilotinib safety profile with time (grade 3-4 AE and of SAE) and causes of death
timeFrame: At one year from study entry
measure: Event Free Survival (EFS)
timeFrame: At one year from study entry
measure: Progression Free Survival (PFS)
timeFrame: At one year from study entry
measure: Rate of point mutations before or after Nilotinib treatment
timeFrame: At one year from study entry
measure: Rate of major cytogenetic response
timeFrame: At one year from study entry
measure: Rate of compete cytogenetic response
timeFrame: At one year from study entry
measure: Rate of major molecular remission
timeFrame: At one year from study entry
Other outcomes:
Locations:
city: Rionero in Vulture
country: Italy
facility: Centro Oncologico Basilicata
state: Potenza
city: Alessandria
country: Italy
facility: Ospedale
city: Alessandria
country: Italy
facility: S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
city: Avellino
country: Italy
facility: S.G. Moscati Hospital
city: Bari
country: Italy
facility: Ospedale
city: Bologna
country: Italy
facility: Ospedale
city: Brescia
country: Italy
facility: Azienda Spedali Civili
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Ferrara
country: Italy
facility: Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
city: Firenze
country: Italy
facility: Policlinico di Careggi, Università delgi studi di Firenze
city: Genova
country: Italy
facility: Clinica Ematologica - Università degli Studi
city: Genova
country: Italy
facility: Università degli Studi
city: Genova
country: Italy
facility: Università di Genova
city: Lecce
country: Italy
facility: ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia
city: Messina
country: Italy
facility: A.O. Universitaria Policlinico Martina di Messina
city: Milano
country: Italy
facility: U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele
city: Napoli
country: Italy
facility: Federico II
city: Orbassano
country: Italy
facility: Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Ospedale Cervello
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
city: Ravenna
country: Italy
facility: Dipartimento Oncologico - Ospedale S.Maria delle Croci
city: Reggio Calabria
country: Italy
facility: Ospedale
city: Rimini
country: Italy
facility: Ospedale
city: Rionero in Vulture
country: Italy
facility: U.O. di Ematologia - Centro Oncologico Basilicata
city: Roma
country: Italy
facility: Ematologia - Sapienza Università di Roma
city: Rome
country: Italy
facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
city: San Giovanni Rotondo
country: Italy
facility: Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
city: Siena
country: Italy
facility: U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
city: Taranto
country: Italy
facility: Ospedale
city: Torino
country: Italy
facility: SCDO Ematologia 2 AOU S. Giovanni Battista
city: Udine
country: Italy
facility: Policlinico Universitario - Clinica Ematologia
city: Verona
country: Italy
facility: Policlinico G. B. Rossi - Borgo Roma
Study officials:
affiliation: Divisione di Medicina Interna-Ematologia, Ospedale San Luigi Gonzaga, Regione Gonzole 10, 10043 Orbassano
name: Giuseppe SAGLIO, Pr.
role: PRINCIPAL_INVESTIGATOR
References: