Clinical trial NCT01251809: Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
Official title: A Randomized, Multi-centre, Parallel-group, Open Label, Oncaspar® Controlled Dose Ranging Trial of Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Acute Lymphoblastic Leukaemia
Keywords: Asparaginase
ALL
Lead sponsor: medac GmbH
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
timeFrame: 3 weeks
Secondary outcomes:
measure: Comparing of treatment arms
timeFrame: 62 days
measure: Comparing of treatment arms
timeFrame: 62 days
measure: Comparing of treatment arms
timeFrame: 62 days
measure: Comparing of treatment arms
timeFrame: 62 days
measure: Comparing of treatment arms
timeFrame: 62 days
measure: Comparing of treatment arms
timeFrame: 62 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin Hämatologie, Onkologie, Transfusionsmedizin Medizinische Klinik III
city: Berlin
country: Germany
facility: Charité University Hospital Campus Virchow
city: Bonn
country: Germany
facility: Universität Bonn, Medizinische Klinik & Poliklinik III
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig Medizinische Klinik III
city: Dresden
country: Germany
facility: Klinikum Carl Gustav Carus der Technischen Universität
city: Duisburg
country: Germany
facility: St. Johannes-Hospital
city: Erlangen
country: Germany
facility: Universität Erlangen-Nürnberg Med. Klinik V/Hämatologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen Westdeutsches Tumorzentrum
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt Medizinische Klinik II
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Hämatologie / Onkologie
city: Hagen
country: Germany
facility: Katholisches Krankenhaus Hagen gGmbH Klinik für Hämatologie und Onkologie
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg Hämatologie & Stammzelltransplantation
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona II. Medizinische Abteilung
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Medizinische Klinik Hämatologie/Onkologie
city: Hannover
country: Germany
facility: Medical University Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: Universität Leipzig José-Carreras-Haus Abt. Hämatologie / Onkologie
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz III. Medizinische Klinik
city: München
country: Germany
facility: Klinikum Schwabing, Klinik für Hämatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie & Tropenmedizin
city: München
country: Germany
facility: Klinikum Rechts der Isar der TU München III. Medizinische Klinik
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg, 5. Medizinische Klinik
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg Innere Medizin II
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
city: Rostock
country: Germany
facility: Universität Rostock, Zentrum für Innere Medizin, Klinik III
city: Stuttgart
country: Germany
facility: Robert Bosch-Krankenhaus Abt. Hämatologie / Onkologie
city: Ulm
country: Germany
facility: Universitätsklinik Ulm Klinik für Innere Medizin III Zentrum für Innere Medizin
city: Würzburg
country: Germany
facility: Klinikum der Universität Würzburg
Study officials:
affiliation: Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt
name: Nicola Gökbuget, MD
role: PRINCIPAL_INVESTIGATOR
References: