A Phase II Study of Dasatinib Therapy in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or With Ph+ Leukemias Resistant or Intolerant to Imatinib

CompletadoFase 2ClinicalTrials.gov

ID: NCT00777036Tipo: INTERVENTIONALInicio: 20 de mar de 2009Fin estimado: 27 de ene de 2025

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Elegibilidad

Edad mínima: 1 DayEdad máxima: 18 YearsSexo: ALL

Criterios de inclusión

Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
CP-CML who prove resistant or intolerant to imatinib (Cohort 1)
Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2)
Newly diagnosed, treatment naive CP-CML (Cohort 3)
Lansky or Karnofsky scale \>50
Life expectancy ≥12 weeks
Adequate hepatic and renal function
Written informed consent
Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation
Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2
Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible

Criterios de exclusión

Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)
Isolated extramedullary disease
Prior therapy with Dasatinib
Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy

Intervenciones

drug

Dasatinib

Ubicaciones

Local Institution - 0043

Bunos Aires, Buenos Aires, Argentina

Local Institution

Bunos Aires, Buenos Aires, Argentina

Hospital Nacional Profesor Alejandro Posadas

El Palomar, Buenos Aires, Argentina

Local Institution - 0049

El Palomar, Buenos Aires, Argentina

Local Institution - 0042

Córdoba, Argentina

Local Institution

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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