Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
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
1 other identifier
interventional
56
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2011
Typical duration for phase_1
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2010
CompletedFirst Posted
Study publicly available on registry
December 2, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 20, 2013
May 1, 2013
1.8 years
November 26, 2010
May 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
3 weeks
Secondary Outcomes (6)
Comparing of treatment arms
62 days
Comparing of treatment arms
62 days
Comparing of treatment arms
62 days
Comparing of treatment arms
62 days
Comparing of treatment arms
62 days
- +1 more secondary outcomes
Study Arms (4)
PEG-rASNase 500
EXPERIMENTAL500 U/m2 BSA at day 0
PEG-rASNase 1000
EXPERIMENTAL1000 U/m2 BSA at day 0
PEG-rASNase 1500
EXPERIMENTAL1500 U/m2 at day 0
Oncaspar
ACTIVE COMPARATOR2000 U/m2 at day 0
Interventions
500, 1000 or 1500 U/m2 BSA single infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- medac GmbHlead
Study Sites (30)
Charité Campus Benjamin Franklin Hämatologie, Onkologie, Transfusionsmedizin Medizinische Klinik III
Berlin, 12200, Germany
Charité University Hospital Campus Virchow
Berlin, 13353, Germany
Universität Bonn, Medizinische Klinik & Poliklinik III
Bonn, 53105, Germany
Städtisches Klinikum Braunschweig Medizinische Klinik III
Braunschweig, 38114, Germany
Klinikum Carl Gustav Carus der Technischen Universität
Dresden, 01307, Germany
St. Johannes-Hospital
Duisburg, 47166, Germany
Universität Erlangen-Nürnberg Med. Klinik V/Hämatologie
Erlangen, 91054, Germany
Universitätsklinikum Essen Westdeutsches Tumorzentrum
Essen, 45147, Germany
Universitätsklinikum Frankfurt Medizinische Klinik II
Frankfurt, 60590, Germany
Universitätsmedizin Göttingen Hämatologie / Onkologie
Göttingen, 37075, Germany
Katholisches Krankenhaus Hagen gGmbH Klinik für Hämatologie und Onkologie
Hagen, 58095, Germany
Asklepios Klinik St. Georg Hämatologie & Stammzelltransplantation
Hamburg, 20099, Germany
Asklepios Klinik Altona II. Medizinische Abteilung
Hamburg, 22763, Germany
Evangelisches Krankenhaus Medizinische Klinik Hämatologie/Onkologie
Hamm, 59063, Germany
Medical University Hannover
Hanover, 30625, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, 24116, Germany
Universität Leipzig José-Carreras-Haus Abt. Hämatologie / Onkologie
Leipzig, 04103, Germany
Universitätsmedizin Mainz III. Medizinische Klinik
Mainz, 55131, Germany
Klinikum Schwabing, Klinik für Hämatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie & Tropenmedizin
München, 80804, Germany
Klinikum Rechts der Isar der TU München III. Medizinische Klinik
München, 81675, Germany
Universitätsklinikum Münster
Münster, 48129, Germany
Klinikum Nürnberg, 5. Medizinische Klinik
Nuremberg, 90419, Germany
Klinikum Oldenburg Innere Medizin II
Oldenburg, 26133, Germany
Klinikum Ernst von Bergmann, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde
Potsdam, 14467, Germany
Klinikum der Universität Regensburg
Regensburg, 93053, Germany
Universität Rostock, Zentrum für Innere Medizin, Klinik III
Rostock, 18057, Germany
Robert Bosch-Krankenhaus Abt. Hämatologie / Onkologie
Stuttgart, 70376, Germany
Universitätsklinik Ulm Klinik für Innere Medizin III Zentrum für Innere Medizin
Ulm, 89070, Germany
Klinikum der Universität Würzburg
Würzburg, 97070, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicola Gökbuget, MD
Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2010
First Posted
December 2, 2010
Study Start
January 1, 2011
Primary Completion
October 1, 2012
Study Completion
May 1, 2013
Last Updated
May 20, 2013
Record last verified: 2013-05