UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 study of pretreatment with hydroxyurea prior to induction therapy for patients with newly diagnosed acute myeloid leukemia (PREFACE study)
Acronym	Phase 2 study of pretreatment with hydroxyurea for newly diagnosed AML
Scientific Title	Phase 2 study of pretreatment with hydroxyurea prior to induction therapy for patients with newly diagnosed acute myeloid leukemia (PREFACE study)
Scientific Title:Acronym	Phase 2 study of pretreatment with hydroxyurea for newly diagnosed AML
Region	Japan

Condition
Condition	Acute myeloid leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of pretreatment with hydroxyurea as a bridge to induction therapy for patients with newly diagnosed acute myeloid leukemia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	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
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hydroxyurea
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key exclusion criteria	1) Past history of allergy to hydroxyurea; 2) Pregnant and/or lactating woman; 3) Serious mental disorder
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Nobuhiko Middle name Last name Emi
Organization	Fujita Health University School of Medicine
Division name	Department of Hematology
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL	0562-93-9243
Email	nemi@fujita-hu.ac.jp

Public contact
1st name of contact person	1st name Nobuhiko Middle name Last name Emi
Organization	Fujita Health University School of Medicine
Division name	Department of Hematology
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL	0562-93-9243
Homepage URL	http://www.fujita-hu.ac.jp/~blood/
Email	nemi@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fujita Health University School of Medicine
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel	0562-93-2139
Email	chiken@fujita-hu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	26
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 16 Day
Date of IRB	2013 Year 11 Month 01 Day
Anticipated trial start date	2013 Year 11 Month 25 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 23 Day
Last modified on	2019 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014487