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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002025
Receipt No. R000002450
Scientific Title 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).
Date of disclosure of the study information 2009/06/01
Last modified on 2017/01/31

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Basic information
Public title 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).
Acronym Multicenter phase II clinical trial for children with relapsed non-T-ALL in intermediate risk group stratified by MRD(JPLSG ALL-R08-II)
Scientific Title 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).
Scientific Title:Acronym 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
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
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)

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

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

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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