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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010488
Receipt No. R000012244
Scientific Title Childrens Cancer and Leukemia Study Group (CCLSG) ALL2004 : A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Lymphoblastic Leukemia
Date of disclosure of the study information 2013/05/01
Last modified on 2013/04/14

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Basic information
Public title Childrens Cancer and Leukemia Study Group (CCLSG) ALL2004 : A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Lymphoblastic Leukemia
Acronym A Multi-Center Phase II Study in Children with ALL: CCLSG ALL2004
Scientific Title Childrens Cancer and Leukemia Study Group (CCLSG) ALL2004 : A Multi-Center Phase II Study in Children with Newly Diagnosed Acute Lymphoblastic Leukemia
Scientific Title:Acronym A Multi-Center Phase II Study in Children with ALL: CCLSG ALL2004
Region
Japan

Condition
Condition Childhood acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safty and effectiveness of rapid and quantitative minimal residual disease (MRD) based therapeutic intesification.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Primary endpoint
1) 3 years event free survival(3y-EFS)
1.1. 3y-EFS difference between
Point1:MRD(-) with Point2:MRD(-)
group and Point1:MRD(+) with
Point2:MRD(-) group
1.2. 3y- EFS improving by the salvage
therapy for Point2:MRD(+) group
Key secondary outcomes Secondary endpoint
1) Severe adverse event rate in each risk-
classification group.
2) Relationship between early prednisolone
response and Poin1- and Point2-MRD.
3) Relationship between day15 bone marrow blast
and Poin1- and Point2-MRD.
4) Relationship among Point3-,4-, 5-, 6-, 7-
(at the end of protocol) MRD and relapse

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 SR: Age 1-9 and initial WBC<50,000mm3
HR: Age 1-9 and initial WBC more than 50,000/mm3 and
WBC<100,000/mm3, or Age 10-19 and initial
WBC<100,000/mm3
HHR: Age 1-19 and initial WBC more than 100,000/mm3
Interventions/Control_2 When point2:MRD more than 0.1%, SR group risk-up to Salvage1, HR and HHR group risk-up to Salvage2.
No optional arm of auto- or 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
1 years-old <=
Age-upper limit
19 years-old >
Gender Male and Female
Key inclusion criteria 1) diagnosis of ALL
2) age more than 1 year old and less than 19 years old.
3) ECOG performance status (PS) acore of 0-3 or Lansky performance status >=30.
4) no history of previous chemotherapy or radiation therapy.
5) sufficient hepatic and renal function satisfying the laboratory data listed below ;
(1) T-Bill <=2 mg/dl
(2) Creatinine: within age adjusted upper-limit of
normal range.
(3) AST: within x4 of the upper-limit of
the institute upper-limit of normal range.
6) ECG showed normal corrected QT
interval.
7) written informed consent obtained from
patient or guardians.
8) Leukemic chimera geen screening has
been investigated.
9) Pregnancy or other inadequate condition
for attending the clinical trial.
Key exclusion criteria 1) mature B-ALL
2) Ph+ALL : After registration, stop the protocol study with information of Ph+.
3) organ dysfunction for attending protocol study.
4) pregnancy or high possibility of pregnancy and giving suck woman.
5) history of congenital or acquired immunodeficiency.
6) uncontrollable infection
7) any inappropriate status judged by
physician.
Target sample size 230

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Arata Watanabe M.D.
Organization Nakadori General Hospital
Division name Department of Pediatrics
Zip code
Address Misonocho 3-15 Minami-dori Akita-shi 010-8577 Japan
TEL 018-833-1122
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hisanari Hori M.D.
Organization Aichi Medical University School of Medicine
Division name Department of Pediatrics
Zip code
Address 21 Gansaku Aza Karimata Nagakude-machi Aichi-gun Aichi-ken 480-1195 Japan
TEL 0561-62-3311
Homepage URL
Email hori@aichi-med-u.ac.jp

Sponsor
Institute Childhood Cancer and Leukemia Study Group (CCLSG)
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
2013 Year 05 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 No longer recruiting
Date of protocol fixation
2004 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 06 Month 01 Day
Last follow-up date
2014 Year 05 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2015 Year 05 Month 31 Day
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 14 Day
Last modified on
2013 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012244

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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