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Acute Lymphoblastic LeukaemiaPhase 1/2NCT01251809

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

A Phase 1/2 study testing Oncaspar and PEG-rASNase in people with Acute Lymphoblastic Leukaemia, run by medac GmbH at 30 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Acute Lymphoblastic Leukaemia
What is being tested?
Oncaspar and PEG-rASNase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
30 sitesGermany
Study dates
Jan 2011to May 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Germany30 sites

  • Charité Campus Benjamin Franklin Hämatologie, Onkologie, Transfusionsmedizin Medizinische Klinik III

    Berlin, 12200

  • Charité University Hospital Campus Virchow

    Berlin, 13353

  • Universität Bonn, Medizinische Klinik & Poliklinik III

    Bonn, 53105

  • Städtisches Klinikum Braunschweig Medizinische Klinik III

    Braunschweig, 38114

  • Klinikum Carl Gustav Carus der Technischen Universität

    Dresden, 01307

  • St. Johannes-Hospital

    Duisburg, 47166

  • Universität Erlangen-Nürnberg Med. Klinik V/Hämatologie

    Erlangen, 91054

  • Universitätsklinikum Essen Westdeutsches Tumorzentrum

    Essen, 45147

  • Universitätsklinikum Frankfurt Medizinische Klinik II

    Frankfurt, 60590

  • Universitätsmedizin Göttingen Hämatologie / Onkologie

    Göttingen, 37075

  • Katholisches Krankenhaus Hagen gGmbH Klinik für Hämatologie und Onkologie

    Hagen, 58095

  • Asklepios Klinik St. Georg Hämatologie & Stammzelltransplantation

    Hamburg, 20099

  • Asklepios Klinik Altona II. Medizinische Abteilung

    Hamburg, 22763

  • Evangelisches Krankenhaus Medizinische Klinik Hämatologie/Onkologie

    Hamm, 59063

  • Medical University Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24116

  • Universität Leipzig José-Carreras-Haus Abt. Hämatologie / Onkologie

    Leipzig, 04103

  • Universitätsmedizin Mainz III. Medizinische Klinik

    Mainz, 55131

  • Klinikum Schwabing, Klinik für Hämatologie, Onkologie, Immunologie, Palliativmedizin, Infektiologie & Tropenmedizin

    München, 80804

  • Klinikum Rechts der Isar der TU München III. Medizinische Klinik

    München, 81675

  • Universitätsklinikum Münster

    Münster, 48129

  • Klinikum Nürnberg, 5. Medizinische Klinik

    Nuremberg, 90419

  • Klinikum Oldenburg Innere Medizin II

    Oldenburg, 26133

  • Klinikum Ernst von Bergmann, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde

    Potsdam, 14467

  • Klinikum der Universität Regensburg

    Regensburg, 93053

  • Universität Rostock, Zentrum für Innere Medizin, Klinik III

    Rostock, 18057

  • Robert Bosch-Krankenhaus Abt. Hämatologie / Onkologie

    Stuttgart, 70376

  • Universitätsklinik Ulm Klinik für Innere Medizin III Zentrum für Innere Medizin

    Ulm, 89070

  • Klinikum der Universität Würzburg

    Würzburg, 97070

Other trials in Germany

About this study

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

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.

Being tested
Oncaspar, PEG-rASNase
Keywords
Asparaginase, ALL
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OncasparDrug

    2000 U/m2 BSA, single infusion

  • PEG-rASNaseDrug

    500, 1000 or 1500 U/m2 BSA single infusion

Study groups in NCT01251809
Study groupRoleWhat they receive
PEG-rASNase 500Experimental500 U/m2 BSA at day 0
Receives: Drug: PEG-rASNase
PEG-rASNase 1000Experimental1000 U/m2 BSA at day 0
Receives: Drug: PEG-rASNase
PEG-rASNase 1500Experimental1500 U/m2 at day 0
Receives: Drug: PEG-rASNase
OncasparActive comparator2000 U/m2 at day 0
Receives: Drug: Oncaspar

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 weeks

Secondary outcomes (6)

  1. Comparing of treatment arms

    -the rate of patients with asparagine depletion

    Measured: 62 days

  2. Comparing of treatment arms

    the rate of patients with L-asparaginase (ASNase) activity levels in serum > 100 U/L

    Measured: 62 days

  3. Comparing of treatment arms

    the duration of ASNase activity levels in serum > 100 U/L and its variability pharmacokinetic parameters Cmax, t½, CLtotal, Kel, AUC0-t and AUC0-∞

    Measured: 62 days

  4. Comparing of treatment arms

    the time profiles of ASNase activity and amino acid levels Asparagine (ASN), Aspartic acid (ASP), Glutamine (GLN) and Glutamic acid (GLU) in serum

    Measured: 62 days

  5. Comparing of treatment arms

    the incidence of increased bilirubin grade III/IV

    Measured: 62 days

  6. Comparing of treatment arms

    the incidence of all other adverse events

    Measured: 62 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionOct 2012
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01251809
Sponsor's protocol ID
MC-PEGASP.1/adults
Status last verified
May 2013
First submitted
26 Nov 2010
Last updated
20 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Oncaspar and PEG-rASNase in people with Acute Lymphoblastic Leukaemia, run by medac GmbH at 30 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01251809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2013.

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