UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009339 |
|---|---|
| Receipt number | R000010967 |
| Scientific Title | Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-B12: A Multi-Center Phase II/III Study in Children with Newly Diagnosed B-cell Precursor Acute Lymphoblastic Leukemia |
| Date of disclosure of the study information | 2012/11/16 |
| Last modified on | 2023/05/25 09:34:59 |
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Basic information
Public title
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-B12:
A Multi-Center Phase II/III Study in Children with Newly Diagnosed B-cell Precursor Acute Lymphoblastic Leukemia
Acronym
A Multi-Center Phase II/III Study in Children with B-cell Precursor ALL: JPLSG ALL-B12
Scientific Title
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-B12:
A Multi-Center Phase II/III Study in Children with Newly Diagnosed B-cell Precursor Acute Lymphoblastic Leukemia
Scientific Title:Acronym
A Multi-Center Phase II/III Study in Children with B-cell Precursor ALL: JPLSG ALL-B12
Region
| Japan |
Condition
Condition
B cell precursor Acute Lymphoblastic Leukemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) To conduct a BFM backbone based nation-wide study and improve the treatment outcome of pediatric B cell precursor acute lymphoblastic leukemia in Japan
2) To establish the nation-wide assessment system of Minimal Residual disease (MRD). 80% of patients would be able to be evaluated the MRD.
3) To test the effectiveness of BFM-95 SR induction including two doses of DNR and DEX/VCR pulse in maintenance for SR patients.
4) To test the effectiveness and safety of intensive L-asaparaginase for IR patients.
5) Abolition of prophylactic cranial radiotherapy by intensive L-asaparaginase and exteded intrathecal therapy for HR patients. Comparison of BFM-HR block therapy vs VCR intensified BFM therapy.
6) To assess the patien'ts QOL in randomized arm in each risk group and search for the clinical parameters affecting patient's QOL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Five years event free survival of each risk group
Key secondary outcomes
1) Five years event free survival, overall survival, and CNS relapse rate of whole group
2) Five years overall survival and CNS relapse rate of each risk group
3) Complete remission rate after induction (IA) and after early intensification (IB) of each risk group and whole group
4) Incidence of adverse events
5) Success rate of MRD estimation at time point 1 and time point 2. Correlation between MRD level and event free survival, overall survival
6) Estimation of quality of life (QOL) by Questionnaire survey to patients and families
7) Exploratory estimation of correlation between biological abnormality and prognosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard Risk(SR) experimental arm:
Criteria: NCI-SR (age<10y and WBC<50,000mm3 ) and prednisolone good responder (PGR) and day15 BM=M1/2 and TP1 BM=M1 without HR features.
Treatment: Reduced intensity BFM backbone treatment.
with VCR/DEX pulse during maintenance phase.
Interventions/Control_2
Standard Risk(SR) control arm:
Criteria: NCI-SR (age<10y and WBC<50,000mm3 ) and prednisolone good responder (PGR) and day15 BM=M1/2 and TP1 BM=M1 without HR features.
Treatment: Reduced intensity BFM backbone treatment.
without VCR/DEX pulse during maintenance phase.
Interventions/Control_3
Intermediate Risk (IR) experimental arm:
Criteria:
(1) NCI-SR (age<10y and WBC<50,000mm3 ) and prednisolone good responder (PGR) and day15 BM=M3 and TP1 BM=M1 without HR features.
(2) NCI-HR (age>10y or WBC>50,000mm3 ) and prednisolone good responder (PGR) and day15 BM=M1/2 and TP1 BM=M1 without HR features.
Treatment: Standard BFM backbone treatment with intensive L-asaparaginase during intensification phase.
Interventions/Control_4
Intermediate Risk (IR) control arm:
Criteria:
(1) NCI-SR (age<10y and WBC<50,000mm3 ) and prednisolone good responder (PGR) and day15 BM=M3 and TP1 BM=M1 without HR features.
(2) NCI-HR (age>10y or WBC>50,000mm3 ) and prednisolone good responder (PGR) and day15 BM=M1/2 and TP1 BM=M1 without HR features.
Treatment: Standard BFM backbone treatment with intensive L-asaparaginase during intensification phase.
Interventions/Control_5
High Risk (HR) experimental arm:
Criteria: at least one of following features
-NCI-HR (age>10y or WBC>50,000mm3) and prednisolone good responder (PGR) and day15 BM=M3
-CNS-3
-prednisolone poor responder (PPR)
-MLL-AF4
-E2A-HLF
-Hypodiploid (<44)
Treatment: BFM backbone tretment with L-asparaginase and intrathecal therapy intensification combined with VCR intensification.
Interventions/Control_6
High Risk (HR) control arm:
Criteria: at least one of following features
-NCI-HR (age>10y or WBC>50,000mm3) and prednisolone good responder (PGR) and day15 BM=M3
-CNS-3
-prednisolone poor responder (PPR)
-MLL-AF4
-E2A-HLF
-Hypodiploid (<44)
Treatment: BFM backbone tretment with L-asparaginase and intrathecal therapy intensification combined with BFM block therapy.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) diagnosis of B cell precursor ALL
2) age between 1 and 19 years old
3) ECOG performance status (PS) score of 0-3
4) no history of previous chemotherapy or radiation therapy
5) sufficient hepatic and renal function satisfying the laboratory data listed below ;
(1) T-Bili: within 3x of age adjusted upper-limit of normal range.
(2) Creatinine: within 3x of age adjusted upper-limit of normal range.
6) written informed consent obtained from
patient or guardians.
Key exclusion criteria
1) mature B-ALL
2) Ph positive ALL
3) True Mixed Lineage Leukemia
4) CNS hemorrage more than grade 3 of CACAE v4.0
5) uncontrolled infection, including active tuberculosis and positive of HIV antibody.
6) pregnancy or high possibility of pregnancy and giving suck wiman.
7) history of congenital or acquired immunodeficiency.
8) QTfc, corrected by Friderics formula as
QTfc = QT/RR*1/3, is more than 0.45 seconds.
9) any inappropriate status judged by
physician.
Target sample size
1560
Research contact person
Name of lead principal investigator
| 1st name | Katsuyoshi |
| Middle name | |
| Last name | Koh |
Organization
Saitama Children's Medical Center
Division name
Department of Hematology/Oncology
Zip code
330-8777
Address
Shintoshin 1-2, Chuo-ku, Saitama-shi, Saitama, Japan
TEL
0486012200
kkohtokyo@gmail.com
Public contact
Name of contact person
| 1st name | Katsuyoshi |
| Middle name | |
| Last name | Koh |
Organization
Saitama Children's Medical Center
Division name
Department of Hematology/Oncology
Zip code
330-8777
Address
Shintoshin 1-2, Chuo-ku, Saitama-shi, Saitama, Japan
TEL
0486012200
Homepage URL
http://www.jplsg.jp/member/shisetu_frm.php
kkohtokyo@gmail.com
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Children's Medical Center, Ethical Committee
Address
Shintoshin 1-2, Chuo-ku, Saitama-shi, Saitama, Japan
Tel
0486012200
n581811@pref.saitama.lg.jp
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
https://ptosh.com/public/organizations/JPLSG/trials/ALL-B12/department_list
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 16 | 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
1940
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010967
