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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015424
Receipt No. R000017936
Scientific Title International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 (IntReALL SR 2010) A randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group
Date of disclosure of the study information 2014/10/14
Last modified on 2020/10/19

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Basic information
Public title International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 (IntReALL SR 2010)

A randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group
Acronym IntReALL SR 2010
Scientific Title International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 (IntReALL SR 2010)

A randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group
Scientific Title:Acronym IntReALL SR 2010
Region
Japan Australia Europe

Condition
Condition Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Improvement of EFS with arm B (ALLR3) compared to arm A (ALL-REZ BFM 2002) in standard risk (SR) patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Event free survival (EFS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 SR armA (ALL-REZ BFM 2002 ,arm Prot II-IDA)
Interventions/Control_2 SR arm B (UK-R3, arm mitoxantrone)
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

Not applicable
Age-upper limit
18 years-old >
Gender Male and Female
Key inclusion criteria Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL.
Children less than 18 years of age at inclusion.
Meeting SR criteria: late isolated or late/early combined BCP BM relapse, any late/early isolated extramedullary relapse.
Patient enrolled in a participating centre.
Written informed consent.
Start of treatment falling into the study period.
No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL.
Key exclusion criteria BCR-ABL / t(9;22) positive ALL.
Pregnancy or positive pregnancy test (urine sample positive for beta-HCG > 10 U/l).
Sexually active adolescents not willing to use highly effective contraceptive method (pearl index < 1) until 2 years after end of antileukemic therapy.
Breast feeding.
Relapse post allogeneic stem-cell transplantation.
The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian.
No consent is given for saving and propagation of pseudonymized medical data for study reasons.
Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders).
Karnovsky / Lansky score < 50%.
Subjects unwilling or unable to comply with the study procedures.
Subjects who are legally detained in an official institute.
Target sample size 456

Research contact person
Name of lead principal investigator
1st name Hidemi
Middle name
Last name Toyoda
Organization Mie University, School of medicine
Division name Deaprtment of Paediatrics
Zip code 514-8507
Address 2-174 Edobashi Tsu
TEL 059-232-1111
Email htoyoda@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Hidemi
Middle name
Last name Toyoda
Organization Mie University, School of medicine
Division name Deaprtment of Paediatrics
Zip code 514-8507
Address 2-174 Edobashi Tsu
TEL 059-232-1111
Homepage URL
Email htoyoda@clin.medic.mie-u.ac.jp

Sponsor
Institute Japanese pediatric leukemia/Lymphoma Study Group
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Review Board for Clinical Trials (Nagoya)
Address 4-1-1 Sannomaru, Naka-ku Nagoya, Aichi
Tel 052-951-1111
Email intreall.committee@nnh.go.jp

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
2014 Year 10 Month 14 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 39
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
2014 Year 07 Month 30 Day
Date of IRB
2014 Year 06 Month 16 Day
Anticipated trial start date
2014 Year 10 Month 14 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 13 Day
Last modified on
2020 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017936

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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