Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
This study has been terminated.
Sponsor:
medac GmbH
Information provided by (Responsible Party):
medac GmbH
ClinicalTrials.gov Identifier:
NCT01251809
First received: November 26, 2010
Last updated: May 17, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukaemia |
Drug: Oncaspar Drug: PEG-rASNase |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by medac GmbH:
Primary Outcome Measures:
- To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]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:
- Comparing of treatment arms [ Time Frame: 62 days ] [ Designated as safety issue: No ]-the rate of patients with asparagine depletion
- Comparing of treatment arms [ Time Frame: 62 days ] [ Designated as safety issue: No ]the rate of patients with L-asparaginase (ASNase) activity levels in serum > 100 U/L
- Comparing of treatment arms [ Time Frame: 62 days ] [ Designated as safety issue: No ]the duration of ASNase activity levels in serum > 100 U/L and its variability pharmacokinetic parameters Cmax, t½, CLtotal, Kel, AUC0-t and AUC0-∞
- Comparing of treatment arms [ Time Frame: 62 days ] [ Designated as safety issue: No ]the time profiles of ASNase activity and amino acid levels Asparagine (ASN), Aspartic acid (ASP), Glutamine (GLN) and Glutamic acid (GLU) in serum
- Comparing of treatment arms [ Time Frame: 62 days ] [ Designated as safety issue: Yes ]the incidence of increased bilirubin grade III/IV
- Comparing of treatment arms [ Time Frame: 62 days ] [ Designated as safety issue: Yes ]the incidence of all other adverse events
| Estimated Enrollment: | 56 |
| Study Start Date: | January 2011 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PEG-rASNase 500
500 U/m2 BSA at day 0
|
Drug: PEG-rASNase
500, 1000 or 1500 U/m2 BSA single infusion
|
|
Experimental: PEG-rASNase 1000
1000 U/m2 BSA at day 0
|
Drug: PEG-rASNase
500, 1000 or 1500 U/m2 BSA single infusion
|
|
Experimental: PEG-rASNase 1500
1500 U/m2 at day 0
|
Drug: PEG-rASNase
500, 1000 or 1500 U/m2 BSA single infusion
|
|
Active Comparator: Oncaspar
2000 U/m2 at day 0
|
Drug: Oncaspar
2000 U/m2 BSA, single infusion
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251809
Locations
| Germany | |
| Charité Campus Benjamin Franklin Hämatologie, Onkologie, Transfusionsmedizin Medizinische Klinik III | |
| Berlin, Germany, 12200 | |
| Charité University Hospital Campus Virchow | |
| Berlin, Germany, 13353 | |
| Universität Bonn, Medizinische Klinik & Poliklinik III | |
| Bonn, Germany, 53105 | |
| Städtisches Klinikum Braunschweig Medizinische Klinik III | |
| Braunschweig, Germany, 38114 | |
| Klinikum Carl Gustav Carus der Technischen Universität | |
| Dresden, Germany, 01307 | |
| St. Johannes-Hospital | |
| Duisburg, Germany, 47166 | |
| Universität Erlangen-Nürnberg Med. Klinik V/Hämatologie | |
| Erlangen, Germany, 91054 | |
| Universitätsklinikum Essen Westdeutsches Tumorzentrum | |
| Essen, Germany, 45147 | |
| Universitätsklinikum Frankfurt Medizinische Klinik II | |
| Frankfurt, Germany, 60590 | |
| Universitätsmedizin Göttingen Hämatologie / Onkologie | |
| Göttingen, Germany, 37075 | |
| Katholisches Krankenhaus Hagen gGmbH Klinik für Hämatologie und Onkologie | |
| Hagen, Germany, 58095 | |
| Asklepios Klinik Altona II. Medizinische Abteilung | |
| Hamburg, Germany, 22763 | |
| Asklepios Klinik St. Georg Hämatologie & Stammzelltransplantation | |
| Hamburg, Germany, 20099 | |
| Evangelisches Krankenhaus Medizinische Klinik Hämatologie/Onkologie | |
| Hamm, Germany, 59063 | |
| Medical University Hannover | |
| Hannover, Germany, 30625 | |
| Universitätsklinikum Heidelberg | |
| Heidelberg, Germany, 69120 | |
| Universitätsklinikum Schleswig-Holstein | |
| Kiel, Germany, 24116 | |
| Universität Leipzig José-Carreras-Haus Abt. Hämatologie / Onkologie | |
| Leipzig, Germany, 04103 | |
| Universitätsmedizin Mainz III. Medizinische Klinik | |
| Mainz, Germany, 55131 | |
| Klinikum Rechts der Isar der TU München III. Medizinische Klinik | |
| München, Germany, 81675 | |
| Klinikum Schwabing, Klinik für Hämatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie & Tropenmedizin | |
| München, Germany, 80804 | |
| Universitätsklinikum Münster | |
| Münster, Germany, 48129 | |
| Klinikum Nürnberg, 5. Medizinische Klinik | |
| Nürnberg, Germany, 90419 | |
| Klinikum Oldenburg Innere Medizin II | |
| Oldenburg, Germany, 26133 | |
| Klinikum Ernst von Bergmann, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde | |
| Potsdam, Germany, 14467 | |
| Klinikum der Universität Regensburg | |
| Regensburg, Germany, 93053 | |
| Universität Rostock, Zentrum für Innere Medizin, Klinik III | |
| Rostock, Germany, 18057 | |
| Robert Bosch-Krankenhaus Abt. Hämatologie / Onkologie | |
| Stuttgart, Germany, 70376 | |
| Universitätsklinik Ulm Klinik für Innere Medizin III Zentrum für Innere Medizin | |
| Ulm, Germany, 89070 | |
| Klinikum der Universität Würzburg | |
| Würzburg, Germany, 97070 | |
Sponsors and Collaborators
medac GmbH
Investigators
| Principal Investigator: | Nicola Gökbuget, MD | Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt |
More Information
No publications provided
| Responsible Party: | medac GmbH |
| ClinicalTrials.gov Identifier: | NCT01251809 History of Changes |
| Other Study ID Numbers: | MC-PEGASP.1/adults |
| Study First Received: | November 26, 2010 |
| Last Updated: | May 17, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by medac GmbH:
|
Asparaginase ALL |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Pegaspargase Asparaginase Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013