UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-I: Prospective observational study
Title of the study (Brief title)	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	Chitose Ogawa
Organization	National Cancer Center Hospital
Division name	Department of Pediatric Oncology
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	Akiko Saito
Organization	Japanese Pediatric Leukemia/Lymphoma study Group
Division name	Data Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 03 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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