UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015424
Receipt number 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 08:27:05

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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 or person

Institute

Japanese pediatric leukemia/Lymphoma Study Group

Institute

Department

Personal name



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

Value
https://center6.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