Lymphoblastic Lymphoma Clinical Trial
— OPALOfficial title:
Part I: Incidence, Clinical Course and Significance of MRI for Early Diagnosis of Osteonecrosis in Children and Adolescents With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) Part II: Susceptibility for Aseptic Osteonecroses in Children and Adolescents With Chemotherapy for ALL or LBL
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | March 2020 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 18 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
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 | 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-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 | Pediatric Hematology and Oncology, University Medicine Greifswald | Greifswald | |
Germany | Clinic of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf | Hamburg | |
Germany | Department of Pediatric and Adolescent Helth, University Medical Center Heidelberg | Heidelberg | |
Germany | Clinic and Polyclinic of Oncology and Haematology, Herdecke | Herdecke | |
Germany | Children's Hospital Medical Center, Pediatric Haematology and Oncology | Homburg | |
Germany | Clinic of Pediatric Hematology and Oncology, Kassel | Kassel | |
Germany | Department of Pediatrics, University Medicine of Schleswig-Holstein, Campus Kiel | Kiel | |
Germany | Clinic of Pediatric and Adolescent Helth, Koblenz-Mayen | Koblenz | |
Germany | Helios Klinikum Krefeld Department of Paediatric and Adolescent Medicine | Krefeld | |
Germany | Clinic of Oncology and Hematology, Johannes Wesling Klinikum | Minden | |
Germany | Department of Paediatric Oncology and Hematology, Cnopf`sche Kinderklinik | Neuendettelsau | |
Germany | Department of General Pediatrics, Hematology and Oncology Oldenburg gGmbH | Oldenburg | |
Germany | Clinic of Paediatric and Adolescend, University Rostock | Rostock | |
Germany | Clinic of Paediatric Oncology and Hematology, Helios Klinikum Schwerin | Schwerin | |
Germany | Clinic Trier, Klinikum Mutterhaus der Bromäerinnen | Trier | |
Germany | Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm | Ulm |
Lead Sponsor | Collaborator |
---|---|
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | occurence of early ON stages | 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 | 6 years | No |
Secondary | ON incidence | Prospective evaluation of incidence of asymptomatic and symptomatic ON in children and adolescents with ALL or LBL | 6 years | No |
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