UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000157
Receipt number 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 10:02:37

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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 or person

Institute

Japan Adult Leukemia Study Group

Institute

Department

Personal name



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

Value
https://center6.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