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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000645
Receipt No. R000000779
Scientific Title Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-P05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Date of disclosure of the study information 2007/03/19
Last modified on 2014/10/06

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Basic information
Public title Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-P05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Acronym AML-P05
Scientific Title Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-P05: A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Promyelocytic Leukemia (APL)
Scientific Title:Acronym AML-P05
Region
Japan

Condition
Condition Acute promyelocytic 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 consisted of 5 courses of multi-agent chemotherapy including ATRA, anthracyclines and cytarabine, followed by single-agent maintenance therapy of ATRA
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
Key secondary outcomes Remission induction rate
Three-year overall survival rate
Rate of adverse events
Rate of DIC or retinoic acid syndrome in the first remission induction therapy
Rate of mortality in the first remission induction therapy
Three-year CNS relapse rate

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 Five courses of multi-agent combination chemotherapy (2 courses for remission induction and 3 for intensification) consisted of ATRA, anthracyclines, and cytarabine, followed by single-agent maintenance chemotherapy of ATRA for all the eligible patients.
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 Patient with a diagnosis of APL
Genetically or cytogenetically diagnosed by either one of three examination; chromosome, FISH, or southern blot
Age less than 18 years old
ECOG performance status score of 0-2, or of 3 when caused by leukemia
No previous treatment
Sufficient hepatic, renal, and cardiac function
Possible clinical observation for more than 3 years
Written informed consent obtained from guardians
Key exclusion criteria CNS hemorrhage which is likely to interfere protocol therapy
Secondary APL due to previous chemotherapy or radiation therapy
Unmanageable infectious disease including tuberculosis
Pregnancy
Septic shock
History of organ transplantation
History of congenital or acquired immunodeficiency
Any inappropriate status judged by physician
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Takahashi
Organization Toho University
Division name Department of Pediatrics
Zip code
Address 6-11-1 Omorinishi, Ota-ku, Tokyo 143-8451
TEL 03(3762)4151
Email taccn@fb3.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Takimoto
Organization JPLSG
Division name Deta Center
Zip code
Address National Nagoya Hospital, 4-1-1, San-nomaru, Naka-ku, Nagoya
TEL 052(951)1111
Homepage URL http://www.jplsg.jp/
Email jplsgdata@nnh.hosp.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

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
2007 Year 03 Month 19 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
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
2005 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2014 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
2007 Year 03 Month 17 Day
Last modified on
2014 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000779

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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