International Study for Treatment of High Risk Childhood Relapsed ALL 2010

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborators: Australian & New Zealand Childhood Hematology & Oncology Group (Co-Sponsor Australia/NZ); Australian & New Zealand Children's Haematology/Oncology Group; Central Manchester University Hospitals NHS Foundation Trust (co-sponsor, UK); Centre Hospitalier Universitaire de Nice; CHU de NICE, Hôpital L'ARCHET (co-sponsor, France); Copenhagen University Hospital, Rigshospitalet (co-sponsor, Denmark); EORTC (Co-Sponsor Belgium); European Organisation for Research and Treatment of Cancer - EORTC; Instituto Português de Oncologia de Lisboa (co-sponsor, Portugal); Karolinska University Hospital Stockholm (co-sponsor, Sweden); Medical University of Wroclaw (Co-Sponsor Poland); Oslo University Hospital (co-sponsor, Norway); Ospedale Pediatrico Bambino (co-sponsor, Italy); Our Lady's Chilrden's Hospital (Co-Sponsor Ireland); Prinses Máxima Centrum (Co-Sponsor Netherlands); Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain); St. Anna Kinderkrebsforschung, CCRI (co-sponsor, Austria); Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel); Turku University Central Hospital (co-sponsor, Finland); University Children's Hospital Zürich (co-sponsor, Switzerland); University Children's Hospital, Zurich; University Hospital Motol (Co-Sponsor Czech Republic)
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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