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A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
Bu çalışma, yeni tanı almış kronik faz Kronik Miyeloid Lösemi (CML) ya da imatinibe dirençli/intoleran Philadelphia kromozomu pozitif lösemisi olan çocuk ve ergenlerde Dasatinib ilacını inceliyor. Uygun karaciğer ve böbrek işlevi olan çocuk hastalar dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * 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 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 * 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 * Target Population for the PK substudy subjects must meet relevant inclusion criteria Exclusion Criteria: * 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 participating in the PK substudy must comply with the relevant exclusion criteria * 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 Other inclusion/exclusion criteria may apply