IntReALL SR 2010
- Conditions
- Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell A
- Registration Number
- JPRN-jRCTs041180122
- Lead Sponsor
- Toyoda Hidemi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 612
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method