coiaward2010

BOSTRO = CML Treated With Bosutinib After Relapse [Spain]

Study title

BOSTRO = CML Treated With Bosutinib After Relapse

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)

Indication and most important 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

Short description of intervention

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

Type of study

Second line trial after treatment failure

Current status

Recruiting

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

Additional information

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

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


 
   
 

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