Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Acute Megakaryoblastic Leukemia
- Myelofibrosis
- Primary Myelofibrosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 pharmacodynamic...
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.
Tracking Information
- NCT #
- NCT02530619
- Collaborators
- The Leukemia and Lymphoma Society
- Millennium Pharmaceuticals, Inc.
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Brady Stein, MD Northwestern University
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