Tests bortezomib in children with high-risk relapsed acute lymphoblastic leukemia
Tests bortezomib added to treatment for children and teens with relapsed leukemia.
Plain-language title generated from the registry record
Registry title: International Study for Treatment of High Risk Childhood Relapsed ALL 2010
Key facts
- Where
- Oslo, NorwaySee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old is the patient who may join a trial?
- What type of cancer has the patient been diagnosed with?
- Is this cancer newly diagnosed, or has it come back or not responded to treatment?
- Is the patient pregnant or breastfeeding?
Source: NCT03590171, who can take part
Where in Norway
- Oslo University HospitalOslo, NorwayNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Charite University, Berlin, Germany
- Trial code
- NCT03590171EU 2024-513070-21-00
- Record updated
- 17 March 2026
- Original description
The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.Read full original descriptionShow less
International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group
The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.
Inclusion: Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL; Children less than 18 years of age at date of inclusion into the study; Meeting HR criteria any BM relapse, early/very early isolated BM relapse, very early isolated/combined 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 day prior to study enrolment that interfere with this protocol, except trials for primary ALL.
Exclusion: Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy; Relapse post allogeneic stem-cell transplantation; 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); Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL; Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) > 10 U/l); Breast feeding; Neuropathy > II°; The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian; Objection to the study participation by a minor patient, able to object; Any patient being dependent on the investigator; No consent is given for saving and propagation of pseudonymized medical data for study reasons; Subjects unwilling or unable to comply with the study procedures; Subjects who are legally detained in an official institute.