Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
- Conditions
- Acute Lymphoblastic Leukaemia
- Interventions
- Drug: PEG-rASNase
- Registration Number
- NCT01251809
- Lead Sponsor
- medac GmbH
- Brief Summary
This is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for determining specific asparaginase doses to yield various durations of L-asparagine (ASN) depletion which are required within different treatment phases of ALL therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 56
- Previously untreated acute lymphoblastic leukaemia (pro-B, common, pre-B, early T, thymic T, mature T)
- 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
- Patients with Philadelphia chromosome (BCR-ABL) positive ALL
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG-rASNase 1000 PEG-rASNase 1000 U/m2 BSA at day 0 PEG-rASNase 500 PEG-rASNase 500 U/m2 BSA at day 0 PEG-rASNase 1500 PEG-rASNase 1500 U/m2 at day 0 Oncaspar Oncaspar 2000 U/m2 at day 0
- Primary Outcome Measures
Name Time Method To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase. 3 weeks To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
- Secondary Outcome Measures
Name Time Method Comparing of treatment arms 62 days the incidence of all other adverse events
Trial Locations
- Locations (30)
Charité Campus Benjamin Franklin Hämatologie, Onkologie, Transfusionsmedizin Medizinische Klinik III
🇩🇪Berlin, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Frankfurt Medizinische Klinik II
🇩🇪Frankfurt, Germany
Charité University Hospital Campus Virchow
🇩🇪Berlin, Germany
Evangelisches Krankenhaus Medizinische Klinik Hämatologie/Onkologie
🇩🇪Hamm, Germany
Universität Bonn, Medizinische Klinik & Poliklinik III
🇩🇪Bonn, Germany
Katholisches Krankenhaus Hagen gGmbH Klinik für Hämatologie und Onkologie
🇩🇪Hagen, Germany
Universitätsklinikum Essen Westdeutsches Tumorzentrum
🇩🇪Essen, Germany
Klinikum Rechts der Isar der TU München III. Medizinische Klinik
🇩🇪München, Germany
Städtisches Klinikum Braunschweig Medizinische Klinik III
🇩🇪Braunschweig, Germany
Universität Erlangen-Nürnberg Med. Klinik V/Hämatologie
🇩🇪Erlangen, Germany
Asklepios Klinik Altona II. Medizinische Abteilung
🇩🇪Hamburg, Germany
Universitätsmedizin Göttingen Hämatologie / Onkologie
🇩🇪Göttingen, Germany
Klinikum Carl Gustav Carus der Technischen Universität
🇩🇪Dresden, Germany
St. Johannes-Hospital
🇩🇪Duisburg, Germany
Asklepios Klinik St. Georg Hämatologie & Stammzelltransplantation
🇩🇪Hamburg, Germany
Medical University Hannover
🇩🇪Hannover, Germany
Universität Leipzig José-Carreras-Haus Abt. Hämatologie / Onkologie
🇩🇪Leipzig, Germany
Klinikum Schwabing, Klinik für Hämatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie & Tropenmedizin
🇩🇪München, Germany
Klinikum Nürnberg, 5. Medizinische Klinik
🇩🇪Nürnberg, 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
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Universität Rostock, Zentrum für Innere Medizin, Klinik III
🇩🇪Rostock, Germany
Universitätsmedizin Mainz III. Medizinische Klinik
🇩🇪Mainz, 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