Osteonecroses in Pediatric Patients With ALL

Lymphoblastic Lymphoma Clinical Trial

— OPAL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01619124
• Other study ID #: DKS 2011.11
• Status: Recruiting
• Phase: N/A
• First received: June 6, 2012
• Last updated: March 4, 2014
• Start date: March 2012
• Est. completion date: March 2020

Study information

• Verified date: March 2014
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Michaela Kuhlen, Dr. med.
• Phone: +49 211 81 17687
• Email: Michaela.Kuhlen[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukaemia
• Leukemia, Lymphoid
• Lymphoblastic Lymphoma
• Lymphoma, Non-Hodgkin
• Osteonecrosis
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immu

Country where clinical trial is conducted

Germany, 

Outcome

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