Osteonecroses in Pediatric Patients With ALL (OPAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01619124
Recruitment Status : Recruiting
First Posted : June 14, 2012
Last Update Posted : March 5, 2014
Information provided by (Responsible Party):
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu, Heinrich-Heine University, Duesseldorf

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.

Condition or disease
Osteonecrosis Acute Lymphoblastic Leukaemia Lymphoblastic Lymphoma

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : March 2012
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2020

Primary Outcome Measures :
  1. occurence of early ON stages [ Time Frame: 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 :
  1. ON incidence [ Time Frame: 6 years ]
    Prospective evaluation of incidence of asymptomatic and symptomatic ON in children and adolescents with ALL or LBL

Biospecimen Retention:   Samples With DNA
whole blood, serum

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, aged >= 10 and < 18 years

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01619124

Contact: Michaela Kuhlen, Dr. med. +49 211 81 17687

Department of Paediatric and Adolescend Medicine, University Aachen Recruiting
Aachen, Germany, 52074
Contact: Rolf Mertens, Prof. Dr.    +49-(0)241-8089902      
Principal Investigator: Rolf Mertens, Prof. Dr.         
Department of Pediatrics, Haematology and Oncology, University Bonn Recruiting
Bonn, Germany, 53113
Contact: Dagmar Dilloo, Prof. Dr.    +49-(0)2873-3254      
Principal Investigator: Carola Weber, Dr. med.         
Department for Children and Adolescent Helth Chemnitz gGmbH Recruiting
Chemnitz, Germany, 09009
Contact: Thomas Scholbach, Prof. Dr.    +49-(0)371-33324124      
Principal Investigator: André Hofmann, Dr. med.         
Clinic of Pediatric and Adolescent Medicine, Vestische Caritas Clinic Datteln Recruiting
Datteln, Germany, 45711
Contact: Thomas Wiesel, Dr.    +49(0)2363-975-392      
Principal Investigator: Thomas Wiesel, Dr.         
Division of Pediatric Hematology and Oncology, University Children´s Hospital Recruiting
Dresden, Germany, 01307
Contact: Meinolf Suttorp, Prof. Dr.    +49-(0)351-4583522      
Principal Investigator: Meinolf Suttorp, Prof. Dr.         
Clinic of Pediatric Oncology, Hematology and Clinical Immunology, Center for Child and Adolescent Health, Heinrich Heine University Recruiting
Duesseldorf, Germany, 40225
Contact: Michaela Kuhlen, Dr. med.    +49(0)211-811-7687   
Clinic of Pediatrics and Adolescent , Pediatric Hematology and Oncology Recruiting
Erlangen, Germany, 91054
Contact: M. Metzler, Dr.    +49-(0)9131-8533117      
Principal Investigator: M. Metzler, Dr.         
Department of Pediatric-Oncology/-Hematology and clin. Immunology, University Medicine Essen Recruiting
Essen, Germany, 45122
Contact: M. Schündeln, Dr.    +49-(0)201-723-84282      
Principal Investigator: M. Schündeln, Dr.         
Department of Pediatric Hematology, Oncology and Hemostaseology, Goethe-University, University Children's Hospital Recruiting
Frankfurt/Main, Germany, 60590
Contact: Thomas Klingebiel, Prof. Dr.    +49-(0)69-6301-5094      
Principal Investigator: Thomas Klingebiel, Prof. Dr.         
Pediatric Hematology and Oncology, University Medicine Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Holger Lode, Prof. Dr.    +49-(0)3834-8622390      
Principal Investigator: Hagen Graf Einsiedel, Dr.         
Clinic of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Reinhard Schneppenheim, Prof. Dr.    +49-(0)74105-3796      
Principal Investigator: Gabriele Escherich, Dr.         
Department of Pediatric and Adolescent Helth, University Medical Center Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Wolfgang Behnisch, Dr.    +49 (0)6221-564555      
Principal Investigator: Wolfgang Behnisch, Dr.         
Clinic and Polyclinic of Oncology and Haematology, Herdecke Recruiting
Herdecke, Germany, 58313
Contact: Alfred Längler, Dr. med.    +49-(0)2330-623893      
Principal Investigator: Alfred Längler, Dr. med.         
Children's Hospital Medical Center, Pediatric Haematology and Oncology Recruiting
Homburg, Germany, 66421
Contact: Norbert Graf, Prof. Dr.    +49-(0)6841-1628411      
Principal Investigator: Norbert Graf, Prof. Dr.         
Clinic of Pediatric Hematology and Oncology, Kassel Recruiting
Kassel, Germany, 34125
Contact: Michaela Nathrath, Prof.    +49 (0)561-980-3504      
Principal Investigator: Michaela Nathrath, Prof.         
Department of Pediatrics, University Medicine of Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Gunnar Cario, Dr.    +49-(0)431-597-1834      
Principal Investigator: Gunnar Cario, Dr.         
Clinic of Pediatric and Adolescent Helth, Koblenz-Mayen Recruiting
Koblenz, Germany, 56073
Contact: Rudolf Ferrari, Dr.    +49 (0)261-499- 2602      
Principal Investigator: Rudolf Ferrari, Dr.         
Helios Klinikum Krefeld Department of Paediatric and Adolescent Medicine Recruiting
Krefeld, Germany, 47805
Contact: Thomas Imschweiler, Dr.    +49-(0)2151-322301      
Contact: Tim Niehues, Prof.Dr.    +49-(0)2151-322301      
Principal Investigator: Thomas Imschweiler, Dr.         
Clinic of Oncology and Hematology, Johannes Wesling Klinikum Recruiting
Minden, Germany, 32429
Contact: Bernhard Erdlenbruch, Prof. Dr.    +49-(0)571-790-54001      
Principal Investigator: Bernhard Erdlenbruch, Prof. Dr.         
Department of Paediatric Oncology and Hematology, Cnopf`sche Kinderklinik Recruiting
Neuendettelsau, Germany, 91564
Contact: Wolfram Scheurlen, Prof. Dr.    +49-(0)911-33403000      
Principal Investigator: Wolfram Scheurlen, Prof.Dr.         
Department of General Pediatrics, Hematology and Oncology Oldenburg gGmbH Recruiting
Oldenburg, Germany, 26133
Contact: Hermann Müller, Prof. Dr.    +49-(0)441-403-2013      
Principal Investigator: H. Müller, Prof. Dr.         
Clinic of Paediatric and Adolescend, University Rostock Recruiting
Rostock, Germany, 18057
Contact: Carl-Friedrich Classen, Dr.    +49-(0)381-4947262      
Principal Investigator: Carl-Friedrich Classen, Dr.         
Clinic of Paediatric Oncology and Hematology, Helios Klinikum Schwerin Recruiting
Schwerin, Germany, 19049
Contact: Christian Güttel, Dr.    +49-(0)385-520-2710      
Principal Investigator: Christian Güttel, Dr.         
Clinic Trier, Klinikum Mutterhaus der Bromäerinnen Recruiting
Trier, Germany, 54290
Contact: Stefan Weis, Dr.    +49-(0)651-94782593      
Principal Investigator: Stefan Weis, Dr.         
Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm Recruiting
Ulm, Germany, 89075
Contact: Klaus-Michael Debatin, Prof. Dr.    +49-(0)731-50057482      
Principal Investigator: Daniel Steinbach, Prof. Dr.         
Sponsors and Collaborators
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu
Study Chair: Michaela Kuhlen, Dr. med. Heinrich-Heine University, Duesseldorf

Responsible Party: Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu, principal investigator and senior physician university paediatric clinic, Heinrich-Heine University, Duesseldorf Identifier: NCT01619124     History of Changes
Other Study ID Numbers: DKS 2011.11
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu, Heinrich-Heine University, Duesseldorf:
acute lymphoblastic leukaemia
lymphoblastic lymphoma

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Diseases
Musculoskeletal Diseases
Pathologic Processes