International Study for Treatment of High Risk Childhood Relapsed ALL 2010
Recruiting now · Phase 2
Conditions studied: Acute Lymphoblastic Leukemia (ALL)
In brief
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.
Key facts
- Study ID
- NCT03590171
- Run by
- Charite University, Berlin, Germany
- People needed
- 250
- Starts
- 2017-09-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-17
Who can join
Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
- Breast feeding
- Relapse post allogeneic stem-cell transplantation
- 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
- 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)
- Subjects unwilling or unable to comply with the study procedures
- Subjects who are legally detained in an official institute
Where it is running
- Australian & New Zealand Childhood Hematology & Oncology Group — Clayton, Victoria, Australia (enrolling)
- St. Anna Kinderkrebsforschung, CCRI — Vienna, Austria (enrolling)
- Hòpital Universitaire des Enfants Reine Fabiola — Brussels, Belgium (enrolling)
- University Hospital Motol — Prague, Czechia (enrolling)
- CHU Nice — Nice, France (enrolling)
- Tel Aviv Sourasky Medical Centre — Tel Aviv, Israel (enrolling)
- Ospedale Pediatrico Bambino Gesù — Roma, Italy (enrolling)
- Prinses Máxima Centrum, Lundlaan — Utrecht, Netherlands (enrolling)
- Dpt. SCT and Hematology/Oncology University Wroclaw — Wroclaw, Poland (enrolling)
- Turku University Central Hospital — Turku, Finland (enrolling)
- Copenhagen University Hospital (Rigshospitalet) — Copenhagen, Denmark
- University Hospital Stockholm — Stockholm, Sweden
- Oslo University Hospital — Oslo, Norway
- Royal Manchester Children's Hospital — Manchester, United Kingdom
- Instituto Português de Oncologia de Lisboa — Lisbon, Portugal
Full record on ClinicalTrials.gov
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