Unique ID issued by UMIN | UMIN000015424 |
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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 |
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
IntReALL SR 2010
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
IntReALL SR 2010
Japan | Australia | Europe |
Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
Hematology and clinical oncology | Pediatrics |
Malignancy
YES
Improvement of EFS with arm B (ALLR3) compared to arm A (ALL-REZ BFM 2002) in standard risk (SR) patients.
Efficacy
Event free survival (EFS)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
SR armA (ALL-REZ BFM 2002 ,arm Prot II-IDA)
SR arm B (UK-R3, arm mitoxantrone)
Not applicable |
18 | years-old | > |
Male and Female
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.
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.
456
1st name | Hidemi |
Middle name | |
Last name | Toyoda |
Mie University, School of medicine
Deaprtment of Paediatrics
514-8507
2-174 Edobashi Tsu
059-232-1111
htoyoda@clin.medic.mie-u.ac.jp
1st name | Hidemi |
Middle name | |
Last name | Toyoda |
Mie University, School of medicine
Deaprtment of Paediatrics
514-8507
2-174 Edobashi Tsu
059-232-1111
htoyoda@clin.medic.mie-u.ac.jp
Japanese pediatric leukemia/Lymphoma Study Group
Health Labour Sciences Research Grant.
Japanese Governmental office
National Hospital Organization Review Board for Clinical Trials (Nagoya)
4-1-1 Sannomaru, Naka-ku Nagoya, Aichi
052-951-1111
intreall.committee@nnh.go.jp
NO
2014 | Year | 10 | Month | 14 | Day |
Unpublished
39
No longer recruiting
2014 | Year | 07 | Month | 30 | Day |
2014 | Year | 06 | Month | 16 | Day |
2014 | Year | 10 | Month | 14 | Day |
2023 | Year | 06 | Month | 30 | Day |
2014 | Year | 10 | Month | 13 | Day |
2020 | Year | 10 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017936
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