UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study for the first relapsed ALL in children. JPLSG ALL-R08-II: Multicenter phase II clinical trial for children with non-T-ALL in intermediate risk group stratified by the minimal residual disease (MRD).
Title of the study (Brief title)	Multicenter phase II clinical trial for children with relapsed non-T-ALL in intermediate risk group stratified by MRD(JPLSG ALL-R08-II)
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 non-T-ALL in S2 risk group, we study the efficacy and the safety of the modified treatment regimen of ALL-REZ BFM 95/96 in which patients with positive MRD after the induction therapy undergo allogeneic stem cell transplantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	3 year-event free survival rate (3y-EFS)
Key secondary outcomes	3 year-overall survival rate(3y-OS) Remission induction rate 3y-EFS and 3y-OS in MRD positive and negative groups Second progression free survival Incidence rates of adverse effects

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients with negative MRD at BMA3, treatment with arm A: chemotherapy
Interventions/Control_2	Patients with positive MRD at BMA3, treatment with arm B: allogeneic stem cell transplantation
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 non-T-ALL and S2 according to ALL-REZ BFM S classification 2. Patients have not received any treatment after relapse. 3. Be<18 years-old at initial diagnosis and be <20 years-old at the enrollment 4. Have adequate hepatic, renal and cardiac function as indicated by laboratory values written in protocol. 5. Have a ECOG Performance Status Score of 0-2. 6. Parents(or leagal guardians) must provide signed, written informed consent.
Key exclusion criteria	1. Patients with mature B-ALL, Ph positive ALL or MLL rearrangement positive ALL. 2. Down syndrome 3. Have any severe bleeding in CNS system. 4. Have an uncontrolled systemic infection. 5. Are pregnant or lactating. 6. Have received a HSCT or organ transplantation. 7. Have a congenital or aquired immunodifficiency syndrome. 8. Patients can not be treated with one or more drugs in the protocol.
Target sample size	69

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
Homepage URL
Email	nsgdata@nnh.hosp.go.jp

Sponsor
Institute	Japanese Peditric 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)

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

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=R000002450