IntReALL SR 2010

JRCT ID: jRCTs041180122

Registered date:23/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
• Date of first enrollment: 15/01/2015
• Target sample size: 612
• Countries of recruitment: Germany,Japan,Australia,Japan,New Zealand,Japan,Austria,Japan,Belgium,Japan,Czech Republic,Japan,Denmark,Japan,Finland,Japan,France,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,Portugal,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,United Kingdom,Japan
• Study type: Interventional
• Intervention(s): Improvement of EFS with arm B (ALLR3) compared to arm A (ALL-REZ BFM 2002) in standard risk (SR) patients.

Outcome(s)

• Primary Outcome: Event free survival

Secondary Outcome

Overall survival
Rate of second complete remission
Toxicity
Rate of stem-cell transplantation
Rate of minimal residual disease negativity

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 17age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Toyoda Hidemi
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000015424