Phase 2 study of pretreatment with hydroxyurea prior to induction therapy for patients with newly diagnosed acute myeloid leukemia (PREFACE study)

Phase 2 study of pretreatment with hydroxyurea prior to induction therapy for patients with newly diagnosed acute myeloid leukemia (PREFACE study) - Phase 2 study of pretreatment with hydroxyurea for newly diagnosed AML

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012389

Enrollment

Registered

2013-11-25

Start date

2013-11-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Interventions

Hydroxyurea

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Previously untreated AML (APL excluded); 2) Age 20 years or older; (3) Performance status between 0 and 3; 4) Adequate functioning of the liver, kidneys, and lungs; 5) Intended for any type of induction therapy; 6) Written informed consent to participate the trial

Exclusion criteria

Exclusion criteria: 1) Past history of allergy to hydroxyurea; 2) Pregnant and/or lactating woman; 3) Serious mental disorder

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactNobuhiko Emi

Fujita Health University School of Medicine Department of Hematology

nemi@fujita-hu.ac.jp0562-93-9243

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026