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

Email

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

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name