UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012389 |
|---|---|
| Receipt number | R000014487 |
| Scientific Title | Phase 2 study of pretreatment with hydroxyurea prior to induction therapy for patients with newly diagnosed acute myeloid leukemia (PREFACE study) |
| Date of disclosure of the study information | 2013/11/25 |
| Last modified on | 2019/05/31 23:46:10 |
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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
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
nemi@fujita-hu.ac.jp
Public contact
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/
nemi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014487
