Phase 2 study of pretreatment with hydroxyurea prior to induction therapy for patients with newly diagnosed acute myeloid leukemia (PREFACE study)
Phase 2
- Conditions
- Acute myeloid leukemia
- Registration Number
- JPRN-UMIN000012389
- Lead Sponsor
- Fujita Health University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
Not provided
Exclusion Criteria
1) Past history of allergy to hydroxyurea; 2) Pregnant and/or lactating woman; 3) Serious mental disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment success rate, defined as a proportion of patients who start induction therapy with their white blood cell counts being less than 30,000/microliter
- Secondary Outcome Measures
Name Time Method Treatment success rate according to initial white blood cell counts higher or lower than 30,000/microliter, complete remission rate with one course of induction therapy, drug-related adverse events (type, severity, and frequency), and relationship between hydroxyurea dosage and response overall survival, and relapse-free survival