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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Universitatsklinikum Heidelberg
      • Kiel, Germany, 24116
        • Universitatsklinikum 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
medac GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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