UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002026
Receipt No. R000002466
Scientific Title Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-I: Prospective observational study
Date of disclosure of the study information 2009/06/01
Last modified on 2017/01/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-I: Prospective observational study
Acronym Prospective observational study for the relapsed ALL in children: JPLSG ALL-R08-I
Scientific Title Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-I: Prospective observational study
Scientific Title:Acronym Prospective observational study for the relapsed ALL in children: JPLSG ALL-R08-I
Region
Japan

Condition
Condition first relapsed acute lymphoblastic leukemia in children
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For the pediatric patients with first relapsed ALL, we study the treatment and the prognosis.
We study the practical treatment and the prognosis in Japanese pediatric patients with first relapsed ALL.
Basic objectives2 Others
Basic objectives -Others observation
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 3 year-event free survival rate(3y-EFS), 3 year-overall survival rate(3y-OS)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
0 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria 1. first relapsed ALL
2. Be<18 year old at initial diagnosis and be <20 year old at the enrollment
3. Parents(or leagal guardians) must provide signed, written informed consent.
Key exclusion criteria Patients with mature B-ALL, Ph chromosome positive ALL or MLL gene rearrangement positive ALL.
Target sample size 88

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chitose Ogawa
Organization National Cancer Center Hospital
Division name Department of Pediatric Oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email chitoseo@qb3.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Saito
Organization Japanese Pediatric Leukemia/Lymphoma study Group
Division name Data Center
Zip code
Address National Nagoya Hospital, 4-1-1, Sannomaru, Naka-ku, Nagoya
TEL 052-951-1111(2751)
Homepage URL http://jplsg
Email nsgdata@nnh.hosp.go.jp

Sponsor
Institute Japanese Peditric Leukemia/Lymphoma Study Group
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
2009 Year 06 Month 01 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
2009 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2016 Year 10 Month 31 Day
Date of closure to data entry
2017 Year 11 Month 01 Day
Date trial data considered complete
2017 Year 11 Month 01 Day
Date analysis concluded
2017 Year 11 Month 01 Day

Other
Other related information 1. 3y-EFS and 3y-OS in total, each risk group and post-transplant relapsed group
remission induction rate in each group
2. 3y-EFS and 3y-OS in S1
3. 3y-EFS, 3y-OS, adverse events and the used drugs with nelaribine
4. Second progression free survival
5. Remission induction rates in each type of treatment regimen
6. Second relapse rate by the treatrent regimen in isolated extramedullary relapse
7. incidence rates of adverse effects
8. Adverse events and prognosis in the transplantation type

Management information
Registered date
2009 Year 06 Month 01 Day
Last modified on
2017 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002466

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.