UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006851 |
|---|---|
| Receipt number | R000008098 |
| Scientific Title | Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-T11 and Japan Adult Leukemia Study Group (JALSG) T-ALL-211-U ALL-T11: A Multi-Center Phase II Study in Children and Adolescence with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia |
| Date of disclosure of the study information | 2011/12/07 |
| Last modified on | 2018/07/18 12:01:02 |
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Basic information
Public title
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-T11 and Japan Adult Leukemia Study Group (JALSG) T-ALL-211-U ALL-T11: A Multi-Center Phase II Study in Children and Adolescence with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia
Acronym
A Multi-Center Phase II Study in Children and Adolescence with T-ALL: JPLSG/JALSG ALL-T11
Scientific Title
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-T11 and Japan Adult Leukemia Study Group (JALSG) T-ALL-211-U ALL-T11: A Multi-Center Phase II Study in Children and Adolescence with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia
Scientific Title:Acronym
A Multi-Center Phase II Study in Children and Adolescence with T-ALL: JPLSG/JALSG ALL-T11
Region
| Japan |
Condition
Condition
T-cell Acute Lymphoblastic Leukemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) Safty and effectiveness of BMF based regimen containing Neralabin.
2) Abolition of prophylactic cranial radiotherapy with Neralabin, intensive L-asparaginase and prolonging intrathecal injection.
3) Restriction of SCT indication using Time-point 2 PCR-MRD.
4) Comparison between PCR-MRD and MRD assayed by flow cytometry.
5) Randomized controlled trial comparing MRD between two consolidation therapy before SCT in VHR group.
6) Comparison effectiveness and safety between pediatrics department and adult hematology department.
7) Evaluation of therapeutic late effect.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1) 3 years event free survival
2) MRD disappearance of VHR group in RCT
Key secondary outcomes
1) Overall survival (OS)
2) Remission induction rate
3) Adverse event (including acute and late effect of patients diagnosed at less than 18 years old)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Stratification(SR/HR/VHR) based on early prednisolone response, remission induction at time-point1(TP1) and MRD at time-point2(TP2).
SR: Early prednisolone good responder (PGR), Time-point1(TP1):BM=M1 and TP2:MRD<10*-3 .
Clinical study question: safety and effectiveness of BFM-MR regimen with intensive L-asp and without Nelarabine.
Interventions/Control_2
HR: Early prednisolone poor responder (PPR), TP1:BM=M1 and TP2:MRD<10*-3 .
Clinical study question: safety and effectiveness of BFM-HR regimen with intensive L-asp and Nelarabine.
Interventions/Control_3
VHR: TP1:BM=M1 and TP2:MRD>=10*-3 or TP1:BM=M2/M3 and TP2:BM=M1.
Clinical study question: rondamization ; BFM-HR block regimen vs high-dose dexamethazine containing regimen.
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) diagnosis of T-ALL (CD3+ or cyCD3+
and more than one is positive among CD2, CD5, CD7, CD8)
2) age less than 25 years old
3) ECOG performance status (PS) acore 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) CNS hemorrage more than grade 3 of CACAE v3.0
2) uncontrolled infection, including active tuberculosis and positive of HIV antibody.
3) pregnancy or high possibility of pregnancy and giving suck wiman.
4) history of congenital or acquired immunodeficiency.
5) Down syndrome.
6) QTfc, corrected by Friderics formula as
QTfc = QT/RR*1/3, is more than 0.45 seconds.
7) any inappropriate status judged by
physician.
Target sample size
147
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Arata Watanabe(JPLSG), Kiyotoshi Imai (JALSG) |
Organization
Nakadori General Hospital (Watanabe)
Sapporp Hokuyu Hospital (Imai)
Division name
Department of Pediatrics (Watanabe), Department of Hematology (Imai)
Zip code
Address
Misonocho 3-15 Minami-dori Akita-shi 010-8577 Japan (Watanabe), 6-6-5-1 Higashi-Sapporo Shiroishi-ku Sapporo 003-0006 Japan (Imai)
TEL
018-833-1122
arata-wa@poppy.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Saito |
Organization
Data center
Division name
OSCR data center
Zip code
Address
National Nagoya Hospital, 4-1-1 Sannomaru Naka-ku Nagoya-city 460-0001, Japan
TEL
052(951)1111
Homepage URL
http://www.jplsg.jp/
oscrdata@nnh.hosp.go.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group
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
| 2011 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
http://www.jplsg.jp/
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 06 | Day |
Last modified on
| 2018 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008098
