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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006851
Receipt No. 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

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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
Email 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/
Email oscrdata@nnh.hosp.go.jp

Sponsor
Institute Japanese Pediatric Leukemia/Lymphoma Study Group
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008098

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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