Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia

May 17, 2013 updated by: medac GmbH

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Charité Campus Benjamin Franklin Hämatologie, Onkologie, Transfusionsmedizin Medizinische Klinik III
      • Berlin, Germany, 13353
        • Charité University Hospital Campus Virchow
      • Bonn, Germany, 53105
        • Universität Bonn, Medizinische Klinik & Poliklinik III
      • Braunschweig, Germany, 38114
        • Städtisches Klinikum Braunschweig Medizinische Klinik III
      • Dresden, Germany, 01307
        • Klinikum Carl Gustav Carus der Technischen Universitat
      • Duisburg, Germany, 47166
        • St. Johannes-Hospital
      • Erlangen, Germany, 91054
        • Universität Erlangen-Nürnberg Med. Klinik V/Hämatologie
      • Essen, Germany, 45147
        • Universitätsklinikum Essen Westdeutsches Tumorzentrum
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Frankfurt Medizinische Klinik II
      • Göttingen, Germany, 37075
        • Universitätsmedizin Göttingen Hämatologie / Onkologie
      • Hagen, Germany, 58095
        • Katholisches Krankenhaus Hagen gGmbH Klinik für Hämatologie und Onkologie
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg Hämatologie & Stammzelltransplantation
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona II. Medizinische Abteilung
      • Hamm, Germany, 59063
        • Evangelisches Krankenhaus Medizinische Klinik Hämatologie/Onkologie
      • Hannover, Germany, 30625
        • Medical University Hannover
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Kiel, Germany, 24116
        • Universitätsklinikum Schleswig-Holstein
      • Leipzig, Germany, 04103
        • Universität Leipzig José-Carreras-Haus Abt. Hämatologie / Onkologie
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz III. Medizinische Klinik
      • München, Germany, 80804
        • Klinikum Schwabing, Klinik für Hämatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie & Tropenmedizin
      • München, Germany, 81675
        • Klinikum Rechts der Isar der TU München III. Medizinische Klinik
      • Münster, Germany, 48129
        • Universitätsklinikum Münster
      • Nürnberg, Germany, 90419
        • Klinikum Nürnberg, 5. Medizinische Klinik
      • Oldenburg, Germany, 26133
        • Klinikum Oldenburg Innere Medizin II
      • Potsdam, Germany, 14467
        • Klinikum Ernst von Bergmann, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde
      • Regensburg, Germany, 93053
        • Klinikum der Universität Regensburg
      • Rostock, Germany, 18057
        • Universität Rostock, Zentrum für Innere Medizin, Klinik III
      • Stuttgart, Germany, 70376
        • Robert Bosch-Krankenhaus Abt. Hämatologie / Onkologie
      • Ulm, Germany, 89070
        • Universitätsklinik Ulm Klinik für Innere Medizin III Zentrum für Innere Medizin
      • Würzburg, Germany, 97070
        • Klinikum der Universität Würzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing of treatment arms
Time Frame: 62 days
-the rate of patients with asparagine depletion
62 days
Comparing of treatment arms
Time Frame: 62 days
the rate of patients with L-asparaginase (ASNase) activity levels in serum > 100 U/L
62 days
Comparing of treatment arms
Time Frame: 62 days
the duration of ASNase activity levels in serum > 100 U/L and its variability pharmacokinetic parameters Cmax, t½, CLtotal, Kel, AUC0-t and AUC0-∞
62 days
Comparing of treatment arms
Time Frame: 62 days
the time profiles of ASNase activity and amino acid levels Asparagine (ASN), Aspartic acid (ASP), Glutamine (GLN) and Glutamic acid (GLU) in serum
62 days
Comparing of treatment arms
Time Frame: 62 days
the incidence of increased bilirubin grade III/IV
62 days
Comparing of treatment arms
Time Frame: 62 days
the incidence of all other adverse events
62 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

medac GmbH

Investigators

  • Principal Investigator: Nicola Gökbuget, MD, Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

November 26, 2010

First Submitted That Met QC Criteria

December 1, 2010

First Posted (Estimate)

December 2, 2010

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-PEGASP.1/adults

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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