International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010

• Status: Active, not recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The main goal of this study is to improve the outcome of children and adolescents with standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany; University Hospital of Berlin
• Collaborators: Australian & New Zealand Children's Haematology/Oncology Group; Central Manchester University (Co-Sponsor United Kingdom); Centre Hospitalier Universitaire de Nice; Copenhagen University Hospital (Rigshospitalet) (Co-Sponsor Copenhagen); European Organisation for Research and Treatment of Cancer - EORTC; Instituto Português de Oncologia de Lisboa (Co-Sponsor Lisboa); Medical University of Wroclaw (Co-Sponsor Poland); National Hospital Organization Nagoya Medical Center (Co-Sponsor Japan); Oslo University Hospital (Co-Sponsor Oslo); Ospedale Pediatrico Bambino Gesù (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 (Co-Sponsor Austria); Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel); Turku University (Co-Sponsor Finland); University Children's Hospital, Zurich; University Hospital Motol (Co-Sponsor Czech Republic); University Hospital Stockholm (Co-Sponsor Sweden)
• Treatments: Epratuzumab

Criteria

Inclusion 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 B-cell precursor (BCP) bone marrow (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 Inclusion criteria specific for the epratuzumab randomization

• Precursor B-cell immunophenotype. A specific CD22 expression level is not required

• M1 or M2 status of the bone marrow after induction

Exclusion Criteria:

• BCR-ABL / t(9;22) positive ALL

• Pregnancy or positive pregnancy test (urine sample positive for β-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