BOSTRO = CML Treated With Bosutinib After Relapse [Spain]
Study title
Scientific title
Single Nucleotide Polymorphism Association With Response and Toxic Effects in Patients With Ph+ CP-CML Treated With Bosutinib After Relapse to Previous Treatment (NCT02445742, EudraCT 2013-004323-372013-004323-37)
Type of study
Second line trial after treatment failure
Current status
Recruitment completed
What is the purpose of the study
This study investigates whether specific features (so called single nucleotide polymorphisms) in genes are related to the activity and adverse effects of bosutinib. The study also evaluates the safety and efficacy of bosutinib in patients after relapse or intolerance to previous tyrosine kinase inhibitors (TKIs).
Patients who have not responded optimally to previous TKI treatment will receive bosutinib 500 mg per day for 2 years, until the disease progresses, unacceptable side effects occur or the patient withdraws consent to participate
Key inclusion criteria
This study includes patients who:
– have Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase (CP-CML)
– have not responded optimally to previous treatment with imatinib, nilotinib or dasatinib, defined as BCR-ABL above 10% at 3 months after starting treatment
– are at least 18 years old
– have recovered from any adverse effects of previous treatments, except for hair loss
– have an Eastern Co-Operative Group (ECOG) status of 0 or 1
– have adequate bone marrow, kidney and liver function
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov,, a service of the U. S. National Institutes of Health
Study sponsor
Fundación PETHEMA para el tratamiento de la leucemia y el linfoma, Spain, with financial support from Pfizer, S.L.U.
Scientific lead / contact
Dr Luis Felipe Casado
PETHEMA
Principal investigator
Dr Luis Felipe Casado
PETHEMA
Study centers / principal investigators
Spain
Gran Canaria
C. H. U. de Gran Canaria Dr. Negrín
Dr. Maite Gómez Casares
Madrid
C. H. Gregorio Marañón
Dr. Santiago Osorio
Madrid
C. U. La Paz – H. U. La Paz
Dr. Raquel de Paz
Madrid
H. Ramón y Cajal
Dr. J. Valentín García Gutiérrez
Madrid
H. U. de la Princesa
Dr. Juan Luis Steegmann
Madrid
H. U. Fundación Jiménez Díaz
Dr. José Luis López Lorenzo
Madrid
Hospital Universitario 12 de Octubre
Dr. Joaquin Martinez
Málaga
C. H. Regional de Málaga , H. General
Dr. Antonio Jiménez Velasco
Palma de Mallorca
H. U. Son Espases
Dr. Andrés Novo
Salamanca
C. Asistencial U. de Salamanca
Dr. Fermín Sánchez Guijo
Santiago de Compostela
C. H. U. de Santiago
Dr. Manuel Pérez Encinas
Toledo
H. Virgen de la Salud
Dr. Luis Felipe Casado
Zaragoza
Clínica Quirón Zaragoza S.A.
Dr. Pilar Giraldo