Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndrome
- Myeloproliferative Neoplasm
- Recurrent Chronic Myelomonocytic Leukemia
- Recurrent Myelodysplastic Syndrome
- Recurrent Myeloproliferative Neoplasm
- Type
- Interventional
- Phase
- Phase 1Phase 2
- 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. To determine the safety, tolerability and maximum tolerable dose (MTD) of quizartinib in combination with azacytidine. II. To assess overall response (ORR) rate to quizartinib in combination with azacitidine. SECONDARY OBJECTIVES: I. To assess overall survival (OS), duration o...
PRIMARY OBJECTIVES: I. To determine the safety, tolerability and maximum tolerable dose (MTD) of quizartinib in combination with azacytidine. II. To assess overall response (ORR) rate to quizartinib in combination with azacitidine. SECONDARY OBJECTIVES: I. To assess overall survival (OS), duration of response, leukemia-free survival (LFS), relapse-free survival (RFS) and safety profile. II. Correlative studies. OUTLINE: This is a phase I, dose-escalation study of quizartinib followed by a phase II study. Patients receive azacitidine subcutaneously (SC) or intravenously (IV) over about 30 minutes on days 1-5 and quizartinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.
Tracking Information
- NCT #
- NCT04493138
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Guillermo M Bravo M.D. Anderson Cancer Center
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