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:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 26, 2010

Last Updated Date

May 17, 2013

Start Date ^ICMJE

January 2011

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

- 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.

Change History

Complete list of historical versions of study NCT01251809 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 (ASN, ASP, GLN and 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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Lymphoblastic Leukaemia

Intervention ^ICMJE

Drug: Oncaspar
2000 U/m2 BSA, single infusion
Drug: PEG-rASNase
500, 1000 or 1500 U/m2 BSA single infusion

Study Arm (s)

Experimental: PEG-rASNase 500
500 U/m2 BSA at day 0

Intervention: Drug: PEG-rASNase
Experimental: PEG-rASNase 1000
1000 U/m2 BSA at day 0

Intervention: Drug: PEG-rASNase
Experimental: PEG-rASNase 1500
1500 U/m2 at day 0

Intervention: Drug: PEG-rASNase
Active Comparator: Oncaspar
2000 U/m2 at day 0

Intervention: Drug: Oncaspar

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

May 2013

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01251809

Other Study ID Numbers ^ICMJE

MC-PEGASP.1/adults

Has Data Monitoring Committee

Yes

Responsible Party

medac GmbH

Study Sponsor ^ICMJE

medac GmbH

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nicola Gökbuget, MD

Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt

Information Provided By

medac GmbH

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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