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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000511
Receipt No. R000000619
Scientific Title Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Myeloid Leukemia
Date of disclosure of the study information 2006/11/01
Last modified on 2015/04/20

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Basic information
Public title Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Myeloid Leukemia
Acronym AML-05
Scientific Title Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Myeloid Leukemia
Scientific Title:Acronym AML-05
Region
Japan

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

Objectives
Narrative objectives1 To evaluate an efficacy and safety of the treatment strategy according to the risk stratification based on leukemia cell biology and response to the initial induction therapy in children less than 18 years old with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia (APL), AML with Down syndrome, secondary AML, AML derived from MDS, AML with multilineage dysplasia, NK/myeloid leukemia, and granulocytic sarcoma.

For the Low Risk group (LR), to evaluate an efficacy and safety of the multi-agent combination chemotherapy consisted of 5 courses, including 4 high-dose cytarabine containing courses, reducing anthracyclines and etoposide compared to AML99 study.
For the Intermediate Risk group (IR), to evaluate an efficacy and safety of the intensified multi-agent combination chemotherapy consisted of 5 courses, including 4 high-dose cytarabine containing courses.
For the High Risk group (HR), to evaluate an efficacy and safety of the intensified multi-agent combination chemotherapy followed by allogeneic hematopoietic stem cell transplantation in first complete remission.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Three-year event-free survival rate of the each risk group
Key secondary outcomes For the each risk group, 3-year EFS; rate of adverse events defined by Common Terminology Criteria for Adverse Events(CTCAE) ver3.0; compliance rate of protocol specified regimen.

Overall, 3-year EFS and OS; induction remission rate; remission rate after initial course of induction chemotherapy; compliance rate of protocol specified regimen.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Two common courses of remission induction multi-agent combination chemotherapy for all the eligible patients.
For Low Risk group (LR), 3 courses of intensification multi-agent combination chemotherapy.
For Intermediate Risk group (IR), 3 courses of intensification multi-agent combination chemotherapy.
For High Risk group (HR), 1 to 3 courses of intensification multi-agent combination chemotherapy followed by allogeneic hematopoietic stem cell transplantation.
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

Not applicable
Age-upper limit
18 years-old >
Gender Male and Female
Key inclusion criteria 1) AML (excluding AML with Down syndrome, APL, secondary AML, NK/myeloid leukemia, and granulocytic sarcoma)
2) age less than 18 years old
3) ECOG performance status score of 0-3
4) no history of previous chemotherapy or radiation therapy
5) sufficient hepatic, renal, and cardiac function satisfying the laboratory data listed below;
T-Bil: within 3x of the age-dependent normal range
ALT: within 10x of the institutional normal range
serum creatinine value: within 3x of the age-dependent normal range
ECG:no severe abnormalities (example; QTc>0.45sec)
6)written informed consent obtained from guardians
Key exclusion criteria 1)CNS hemorrhage which is likely to interfere protocol therapy
2)uncontrolled DM
3)severe mental abnormalities
4)pregnancy
5)unmanageable infectious disease
6)history of congenital or acquired immunodeficiency
7)any inappropriate status judged by physician

Target sample size 254

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Tawa
Organization National Hospital Organization Osaka National Hospital
Division name Department of Pediatrics
Zip code
Address 2-1-14Hoenzaka, Chuo-ku, Osaka city
TEL 06-6942-1331
Email tawa@onh.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akio Tawa
Organization National Hospital Organization Osaka National Hospital
Division name Department of Pediatrics
Zip code
Address 2-1-14Hoenzaka, Chuo-ku, Osaka city
TEL 06-6942-1331
Homepage URL http://www.jplsg.jp/
Email tawa@onh.go.jp

Sponsor
Institute Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour 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
2006 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1. CR rate, 3-year EFS and OS rates for the whole cohort (N=443)
CR rate: 86.0%
3-year EFS: 54.3 % (95%CI, 49.3-59.0%)
3-year OS: 73.2 % (95%CI, 68.3-77.4%)
3-year relapse rate: 30.3% (95%CI, 25.9-34.7%)

2. 3-year EFS and OS rates according to the risk group
1) Low risk (LR) group (N=135)
3-year EFS: 69.4 % (95%CI, 60.3-76.8%)
3-year OS: 92.5 % (95%CI, 85.5-96.3%)
2) Intermediate risk (IR) group (N=183)
3-year EFS: 57.3 % (95%CI, 49.3-64.5%)
3-year OS: 73.2 % (95%CI, 65.0-79.8%)
3) High risk (HR) group (N=54)
3-year EFS: 53.4 % (95%CI, 39.2-65.6%)
3-year OS: 66.8 % (95%CI, 51.1-78.4%)
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
2006 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2012 Year 05 Month 01 Day
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information Amendment of induction therapy for the patients less than 1 year old at diagnosis:
#1 Unacceptable treatment-related death noted in six of the first 32 infant cases enrolled on JPLSG AML-05 has led to the suspension of study enrollment for the patients less than 1 year of age in April 2nd, 2009.
#2 The JPLSG AML committee has decided to amend the study to reduce the drug doses in the first course of induction therapy and to add a new safety monitoring rules for toxic deaths for the infant cases.
#3 The protocol was amended on August 4th, 2009, and the study enrollment for the patients less than 1 year old at diagnosis was re-started.

Management information
Registered date
2006 Year 10 Month 31 Day
Last modified on
2015 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000619

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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