UMIN-CTR Clinical Trial

Basic information
Public title	Phase III Randomized Study of Induction Therapy Comparing Daunorubicin With Idarubicin Followed By Consolidation Therapy Comparing High-Dose Cytarabine With Sequential Multiagent Chemotherapy in Patients With Previously Untreated De Novo Acute Myeloid Leukemia (JALSG AML201 Study)
Acronym	Randomized Study of Induction and Consolidation Therapy in Patients With Previously Untreated AML (JALSG AML201 Study)
Scientific Title	Phase III Randomized Study of Induction Therapy Comparing Daunorubicin With Idarubicin Followed By Consolidation Therapy Comparing High-Dose Cytarabine With Sequential Multiagent Chemotherapy in Patients With Previously Untreated De Novo Acute Myeloid Leukemia (JALSG AML201 Study)
Scientific Title:Acronym	Randomized Study of Induction and Consolidation Therapy in Patients With Previously Untreated AML (JALSG AML201 Study)
Region	Japan

Condition
Condition	Acute Myeloid Leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Compare Daunorubicin With Idarubicin in Induction Therap Compare High-Dose Cytarabine With Sequential Multiagent Chemotherapy in Consolidation Therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Complete remission rate in induction therapy Relapse-free survival
Key secondary outcomes	Overall survival Toxicity more than grade 2

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Daunorubicin
Interventions/Control_2	Idarubicin
Interventions/Control_3	High-Dose Cytarabine
Interventions/Control_4	Sequential Multiagent Chemotherapy
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Newly diagnosed AML (except M3) 2. PS 0-3 (ECOG) 3. Adequate hepatic, renal, pulmonary and cardiac function 4. Written informed consent
Key exclusion criteria	1. Atypical leukemia 2. History of MDS 3. History of cancer chemotherapy 4. Other active neoplasms 5. Recent history of myocardial infarction or renal failure, 6. Severe comorbidity (diabetes mellitus, infection or liver cirrhosis) 7. Psychological disorders 8. Pregnant and/or lactating woman 9. Positive anti-HIV antibody
Target sample size	850

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigeki Ohtake
Organization	Kanazawa University, Graduate School of Medical Science
Division name	Department of Clinical Laboratory Science
Zip code
Address	5-11-80 Kodatsuno, Kanazawa, Ishikawa
TEL	076-265-2602
Email

Public contact
Name of contact person	1st name Middle name Last name Shigeki Ohtake
Organization	JALSG AML201 Study Office
Division name	Kanazawa University, Graduate School of Medical Science, Department of Clinical Laboratory Science
Zip code
Address	5-11-80 Kodatsuno, Kanazawa, Ishikawa
TEL	076-265-2602
Homepage URL	http://www.jalsg.jp/
Email	sohtake@med3.m.kanazawa-u.ac.jp

Sponsor
Institute	Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2005 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	2001 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date	2001 Year 12 Month 01 Day
Last follow-up date	2008 Year 08 Month 01 Day
Date of closure to data entry	2008 Year 08 Month 01 Day
Date trial data considered complete	2008 Year 09 Month 01 Day
Date analysis concluded	2008 Year 10 Month 01 Day

Other
Other related information	Published in Blood. 117(8): 2358 - 2365, 2011. Blood. 117(8): 2366 - 2372, 2011.

Management information
Registered date	2005 Year 09 Month 11 Day
Last modified on	2011 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000227

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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