Trial try to assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600.
This is a single-arm, open-label, phase II trial for patients in complete cytogenetic response that have not achieved major molecular response or have lost a prior major molecular response, after at least 18 months of treatment with imatinib. All enrolled patients will receive dasatinib 100 mg once daily orally for 1 year until progression, loss of cytogenetic response, transformation to advanced phases, unacceptable toxicity (clinical adverse event, lab abnormality or concurrent disease), pregnancy if a female or withdrawal of consent, whichever happens first. Patients will undergo BCR-ABL assessments at study entry and every 3 months (central lab) and immunophenotyping and studies for clonal lymphocytosis at study entry, at 3 and 6 months. Cytogenetic assessment will be done only if loss of response/progression/clonal evolution are suspected. Subjects will be evaluated for the efficacy and safety of dasatinib (Sprycel). Lymphocytosis data will be collected for all patients and separate description for efficacy and safety parameters will be done in patients with and without lymphocytosis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Hospital Txagorritxu
Vitoria-Gasteiz, Alava, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Institut Catalá d'Oncologia L'Hospitallet
Asses the efficacy
To assess the efficacy of dasatinib in terms of major molecular response rate at 6 months in patients with CP-CML who have achieved complete cytogenetic response without major molecular response after at least 18 months on Imatinib 400/600
Time frame: 1 year
Asses the efficacy
To assess the efficacy of dasatinib in terms of depth and kinetics of molecular response
Time frame: 1 year
Assess the relationship of dasatinib with the appearance of large granular lymphocytes
To assess the relationship of dasatinib with the appearance of large granular lymphocytes and assess the relationship of LGL with efficacy and toxicity
Time frame: 6 months
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Barcelona, Barcelona, Spain
Complejo Hospitalario de Toledo - Hospital Virgen de la Salud
Toledo, Castille-La Mancha, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain
Hospital San Pedro de La Rioja
Logroño, La Rioja, Spain
Hospital de León
León, León, Spain
Hospital Universitario de la Princesa
Madrid, Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital 12 de Octubre
Madrid, Madrid, Spain
...and 5 more locations