UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002025 |
|---|---|
| Receipt number | 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 12:41:20 |
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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
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
nsgdata@nnh.hosp.go.jp
Sponsor or person
Institute
Japanese Peditric Leukemia/Lymphoma Study Group(JPLSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002450
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