Eltrombopag Olamine in Treating Thrombocytopenia in Patients With Chronic Myeloid Leukemia or Myelofibrosis Receiving Tyrosine Kinase Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 29
Summary
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Primary Myelofibrosis
- Thrombocytopenia
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the efficacy of eltrombopag (eltrombopag olamine) for patients with chronic myeloid leukemia (CML) or myelofibrosis (MF) who have developed thrombocytopenia during the course of therapy with tyrosine kinase inhibitors (TKI) as measured by recovery of platelet coun...
PRIMARY OBJECTIVES: I. To determine the efficacy of eltrombopag (eltrombopag olamine) for patients with chronic myeloid leukemia (CML) or myelofibrosis (MF) who have developed thrombocytopenia during the course of therapy with tyrosine kinase inhibitors (TKI) as measured by recovery of platelet count. SECONDARY OBJECTIVES: I. To determine the safety of eltrombopag for patients with CML or MF who have developed thrombocytopenia during the course of therapy with TKI. II. To determine the dose intensity of TKI after start of therapy with eltrombopag. III. To determine response to TKI after start of therapy with eltrombopag. OUTLINE: Patients receive eltrombopag olamine orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Tracking Information
- NCT #
- NCT01428635
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Gautam Borthakur M.D. Anderson Cancer Center
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