Osteonecroses in Pediatric Patients With ALL (OPAL)

March 4, 2014 updated by: Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, aged >= 10 and < 18 years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ON incidence
Time Frame: 6 years
Prospective evaluation of incidence of asymptomatic and symptomatic ON in children and adolescents with ALL or LBL
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu

Investigators

  • Study Chair: Michaela Kuhlen, Dr. med., Heinrich-Heine University, Duesseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ANTICIPATED)

March 1, 2016

Study Completion (ANTICIPATED)

March 1, 2020

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (ESTIMATE)

June 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DKS 2011.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoblastic Lymphoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe