Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Northwestern University
With
PRIMARY OBJECTIVES: I. Determine the safety profile of alisertib in patients with acute megakaryoblastic leukemia (AMKL) and in patients with myelofibrosis (MF). SECONDARY OBJECTIVES: I. Determine preliminary efficacy of alisertib in both populations. TERCIARY OBJECTIVES: I. Describe pharmacodynamics (PD) effects of alisertib in peripheral blood and/or bone marrow samples. II. Evaluate the relationship between biomarker expression levels and response to alisertib. III. Evaluate reduction in splenomegaly by palpation (MF arm only). IV. Evaluate improvement in MF symptoms (MF arm only), as assessed by the Myeloproliferative Neoplasm Symptom Assessment form (MPN-SAF). V. Assess change in bone marrow fibrosis in patients in the MF arm. OUTLINE: Patients receive alisertib orally (PO) twice daily (BID) on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at approximately 30 days and 6 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
