UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010488 |
|---|---|
| Receipt number | 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 11:15:29 |
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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
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
hori@aichi-med-u.ac.jp
Sponsor or person
Institute
Childhood Cancer and Leukemia Study Group (CCLSG)
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012244
