UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	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)
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	Akiko Saito
Organization	Data center
Division name	OSCR data center
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 09 Month 01 Day
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

Related information
URL releasing protocol	http://www.jplsg.jp/
Publication of results	Unpublished
URL releasing results
Results
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