Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
NCT ID: NCT01251809
Last Updated: 2013-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2011-01-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PEG-rASNase 500
500 U/m2 BSA at day 0
PEG-rASNase
500, 1000 or 1500 U/m2 BSA single infusion
PEG-rASNase 1000
1000 U/m2 BSA at day 0
PEG-rASNase
500, 1000 or 1500 U/m2 BSA single infusion
PEG-rASNase 1500
1500 U/m2 at day 0
PEG-rASNase
500, 1000 or 1500 U/m2 BSA single infusion
Oncaspar
2000 U/m2 at day 0
Oncaspar
2000 U/m2 BSA, single infusion
Interventions
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Oncaspar
2000 U/m2 BSA, single infusion
PEG-rASNase
500, 1000 or 1500 U/m2 BSA single infusion
Eligibility Criteria
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Inclusion Criteria
* Age 18 years - 55 years
* Treatment according to German Multicenter Trials for adult Acute Lymphoblastic Leukaemia (GMALL) 07/2003 protocol or subsequent GMALL protocols for patients with de novo ALL
* Written informed consent
* Women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception
* Negative pregnancy test for women of child-bearing potential
Exclusion Criteria
* Severe comorbidity or leukaemia-associated complications
* Known hypersensitivity to asparaginase
* History of severe pancreatitis
* History of thrombosis or pulmonary embolism
* Pre-existing clinically relevant coagulopathy
* Liver dysfunction (e.g. acute or current hepatitis, alcohol or drug abuse) or history of clinically relevant liver disease
* Bilirubin \> 1.5 x Upper Limit Norm (ULN)
* Other current malignancies
* Severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent
* Body mass index \> 30 kg/m²
* Known pregnancy, breast feeding
18 Years
55 Years
ALL
No
Sponsors
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medac GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Nicola Gökbuget, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt
Locations
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Charité Campus Benjamin Franklin Hämatologie, Onkologie, Transfusionsmedizin Medizinische Klinik III
Berlin, , Germany
Charité University Hospital Campus Virchow
Berlin, , Germany
Universität Bonn, Medizinische Klinik & Poliklinik III
Bonn, , Germany
Städtisches Klinikum Braunschweig Medizinische Klinik III
Braunschweig, , Germany
Klinikum Carl Gustav Carus der Technischen Universität
Dresden, , Germany
St. Johannes-Hospital
Duisburg, , Germany
Universität Erlangen-Nürnberg Med. Klinik V/Hämatologie
Erlangen, , Germany
Universitätsklinikum Essen Westdeutsches Tumorzentrum
Essen, , Germany
Universitätsklinikum Frankfurt Medizinische Klinik II
Frankfurt, , Germany
Universitätsmedizin Göttingen Hämatologie / Onkologie
Göttingen, , Germany
Katholisches Krankenhaus Hagen gGmbH Klinik für Hämatologie und Onkologie
Hagen, , Germany
Asklepios Klinik St. Georg Hämatologie & Stammzelltransplantation
Hamburg, , Germany
Asklepios Klinik Altona II. Medizinische Abteilung
Hamburg, , Germany
Evangelisches Krankenhaus Medizinische Klinik Hämatologie/Onkologie
Hamm, , Germany
Medical University Hannover
Hanover, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Universität Leipzig José-Carreras-Haus Abt. Hämatologie / Onkologie
Leipzig, , Germany
Universitätsmedizin Mainz III. Medizinische Klinik
Mainz, , Germany
Klinikum Schwabing, Klinik für Hämatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie & Tropenmedizin
München, , Germany
Klinikum Rechts der Isar der TU München III. Medizinische Klinik
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Klinikum Nürnberg, 5. Medizinische Klinik
Nuremberg, , Germany
Klinikum Oldenburg Innere Medizin II
Oldenburg, , Germany
Klinikum Ernst von Bergmann, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde
Potsdam, , Germany
Klinikum der Universität Regensburg
Regensburg, , Germany
Universität Rostock, Zentrum für Innere Medizin, Klinik III
Rostock, , Germany
Robert Bosch-Krankenhaus Abt. Hämatologie / Onkologie
Stuttgart, , Germany
Universitätsklinik Ulm Klinik für Innere Medizin III Zentrum für Innere Medizin
Ulm, , Germany
Klinikum der Universität Würzburg
Würzburg, , Germany
Countries
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Other Identifiers
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MC-PEGASP.1/adults
Identifier Type: -
Identifier Source: org_study_id
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