coiaward2010

BEST - Bosutinib in Elderly Chronic Myeloid Leukemia [Italy]

Study title

Bosutinib in Elderly Chronic Myeloid Leukemia (BEST)

Scientific title

Bosutinib Efficacy, Safety, Tolerability (BEST) Study in Elderly Chronic Myeloid Leukemia Patients Failing Front-line Treatment With Other Tyrosine Kinase Inhibitors (ClinicalTrials.gov NCT02810990)

Indication and most important inclusion criteria

Male or female patients 60 years of age or older with a molecular confirmed diagnosis of BCR-ABL1+ CML in chronic phase and prior first-line treatment with any other tyrosine kinase inhibitor.
Patients can be considered for inclusion in the study if they are intolerant to prior treatment, based on investigator and patient assessment, or have not responded to prior treatment (assessed according to any one of the ELN 2013 criteria).

Short description of intervention

The purpose of this study is to evaluate the tyrosine kinase inhibitor (TKI) bosutinib in elderly patients who did not obtain any benefit with other drugs before.

The median age of newly diagnosed CML patients is about 56 years, and at least 40% of all newly diagnosed patients are over 60 years old. Particularly for these elderly patients, the choice of TKI must take into account the safety and tolerability profile of the drug. This study tests the efficacy, safety and tolerability of bosutinib in second-line treatment, beginning with a low dose (200 mg once daily) and adjusting subsequent doses (up to 400 mg once daily) based on molecular response and on adverse events.

Type of study

Trial after therapy failure or intolerance

Current status

Recruiting

Study sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Scientific lead / contact

Prof. Gianantonio Rosti
Department of Oncology and Hematology
O.U. of Hematology
S. Orsola-Malpighi University Hospital
Bologna, Italy

Principal investigator

Prof. Gianantonio Rosti
Department of Oncology and Hematology
O.U. of Hematology
S. Orsola-Malpighi University Hospital
Bologna, Italy

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Italy

Bologna
S. Orsola-Malpighi University Hospital
G. Rosti

Cagliari
"A. Businco"
E. Usala

Catania
F. Stagno

Ferrara
F. Cavazzini

Genova
IRCCS San Martino
M. Gobbi

Meldola
IRST
A. Lucchesi

Messina
Policlinico G. Martino
C. Musolino

Milano
Ist. Nazionale Tumori
F. Spina

Milano
Osp. Maggiore Policlinico
A.Iurlo

Milano
Ospedale San Raffaele
F. Ciceri

Napoli
Univ. Studi Napoli "Federico II"
F. Pane

Novara
M. Lunghi

Orbassano
C. Rege Cambrin

Parma
M. Crugnola

Piacenza
D. Vallisa

Ravenna
M. Salvucci

Reggio Emilia
I. Capodanno

Rimini
A. L. Molinari

Roma
Gemelli
F. Sorà

Roma
Ospedale Sant'Eugenio
E. Abruzzese

Roma
San Giovanni Addolorata
M. Cedrone

San Giovanni Rotondo
N. Cascavilla

Siena
M. Bocchia

Torino
Città della salute e della scienza
D. Ferrero

Verona
M. Bonifacio