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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000157
Receipt No. R000000227
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)
Date of disclosure of the study information 2005/09/12
Last modified on 2011/09/09

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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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