Osteonecroses in Pediatric Patients With ALL

• Conditions: Osteonecrosis; Acute Lymphoblastic Leukaemia; Lymphoblastic Lymphoma

• Registration Number: NCT01619124
• Lead Sponsor: Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu

Brief Summary

Nowadays approximately 80% of children and adolescents with acute lymphoblastic leukaemia (ALL) or lymphoblastic lymphoma (LBL) can be cured and become long-term survivors. Avascular osteonecroses (ON) appear as serious side-effect of antileukaemic treatment. Frequently ON are first diagnosed at higher and than irreversible stages (ARCO III, IV). At these advanced stages curative treatment options are not available. Hence ON are associated with considerable morbidity concerning pain and immobility and go along with long-term impairment of quality of life. Therefore early diagnosis of ON in the follow-up of children and young adults with ALL or LBL is a pressing object.

Within the prospective multicentric observational OPAL-trial patients at risk (aged 10 years or older) treated according to the clinical trials ALL-BFM(Berlin-Frankfurt-Muenster Study Group), COALL or NHL (Non Hodgkin Lymphoma)-BFM in Germany should be examined with regard to the development of ON. By using a treatment associated, risk orientated assessment and examination incidence, symptoms and the clinical course of ON are investigated. The validity of MRI screening in the early diagnosis of ON in children and young adults is analysed.

Systematical investigation of patients under antileukaemic treatment is intended to contribute to risk adapted diagnostic strategies and to serve as data base for the subsequent evaluation of preventive and interventional approaches for the treatment of ON. Long-term objective is the reduction of ON-associated morbidity.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-14
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05
• Primary Completion: 2016-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• diagnosis of ALL or LBL
• age at diagnosis of ALL or LBL ≥ 10 and < 18 years
• study patient of AIEOP( Associazione Italiana Ematologia ed Oncologia Pediatrica)-BFM, COALL or NHL-BFM in Germany
• treatment in a hospital participating in OPAL
• written informed consent

Exclusion Criteria

• relapse of ALL or LBL
• every non evidence based treatment (pharmacological, orthopaedic-conservative, orthopaedic operative) aiming at the prevention of ON during study participation
• pacemaker, other MRI prohibited devices
• metal implants in the field of view, other MRI prohibited implants
• pregnancy
• claustrophobia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
occurence of early ON stages	6 years	Calculation of the rate of by MRI detectable (still) asymptomatic patients with early ON stages (I and II) within the patients who develop symptomatic ON in the further course

Secondary Outcome Measures

Name	Time	Method
ON incidence	6 years	Prospective evaluation of incidence of asymptomatic and symptomatic ON in children and adolescents with ALL or LBL

Trial Locations

Locations (25)

Children's Hospital Medical Center, Pediatric Haematology and Oncology; 🇩🇪 Homburg, Germany

Department of General Pediatrics, Hematology and Oncology Oldenburg gGmbH; 🇩🇪 Oldenburg, Germany

Clinic of Pediatric Hematology and Oncology, Kassel; 🇩🇪 Kassel, Germany

Department of Pediatrics, University Medicine of Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Germany

Clinic Trier, Klinikum Mutterhaus der Bromäerinnen; 🇩🇪 Trier, Germany

Clinic of Pediatric and Adolescent Helth, Koblenz-Mayen; 🇩🇪 Koblenz, Germany

Helios Klinikum Krefeld Department of Paediatric and Adolescent Medicine; 🇩🇪 Krefeld, Germany

Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm; 🇩🇪 Ulm, Germany

Clinic of Oncology and Hematology, Johannes Wesling Klinikum; 🇩🇪 Minden, Germany

Department of Paediatric Oncology and Hematology, Cnopf'sche Kinderklinik; 🇩🇪 Neuendettelsau, Germany

Clinic of Paediatric Oncology and Hematology, Helios Klinikum Schwerin; 🇩🇪 Schwerin, Germany

Clinic of Paediatric and Adolescend, University Rostock; 🇩🇪 Rostock, Germany

Department of Paediatric and Adolescend Medicine, University Aachen; 🇩🇪 Aachen, Germany

Department of Pediatrics, Haematology and Oncology, University Bonn; 🇩🇪 Bonn, Germany

Department for Children and Adolescent Helth Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Clinic of Pediatric and Adolescent Medicine, Vestische Caritas Clinic Datteln; 🇩🇪 Datteln, Germany

Division of Pediatric Hematology and Oncology, University Children´s Hospital; 🇩🇪 Dresden, Germany

Department of Pediatric-Oncology/-Hematology and clin. Immunology, University Medicine Essen; 🇩🇪 Essen, Germany

Department of Pediatric Hematology, Oncology and Hemostaseology, Goethe-University, University Children's Hospital; 🇩🇪 Frankfurt/Main, Germany

Clinic of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Heinrich Heine University; 🇩🇪 Duesseldorf, Germany

Clinic of Pediatrics and Adolescent , Pediatric Hematology and Oncology; 🇩🇪 Erlangen, Germany

Department of Pediatric and Adolescent Helth, University Medical Center Heidelberg; 🇩🇪 Heidelberg, Germany

Clinic and Polyclinic of Oncology and Haematology, Herdecke; 🇩🇪 Herdecke, Germany

Clinic of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Pediatric Hematology and Oncology, University Medicine Greifswald; 🇩🇪 Greifswald, Germany