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Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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

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

NCT01251809•medac GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (30)

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

Berlin, Germany

Charité University Hospital Campus Virchow

Berlin, Germany

Universität Bonn, Medizinische Klinik & Poliklinik III

Bonn, Germany

Städtisches Klinikum Braunschweig Medizinische Klinik III

Braunschweig, Germany

Klinikum Carl Gustav Carus der Technischen Universität

Dresden, Germany

St. Johannes-Hospital

Duisburg, Germany

Universität Erlangen-Nürnberg Med. Klinik V/Hämatologie

Erlangen, Germany

Universitätsklinikum Essen Westdeutsches Tumorzentrum

Essen, Germany

Universitätsklinikum Frankfurt Medizinische Klinik II

Frankfurt, Germany

Universitätsmedizin Göttingen Hämatologie / Onkologie

Göttingen, Germany

Key Dates

Start Date

January 1, 2011

Primary Completion Date

October 1, 2012

Completion Date

May 1, 2013

Last Updated

May 20, 2013

Enrollment

ESTIMATED participants

Conditions

Acute Lymphoblastic Leukaemia

Interventions

Oncaspar

DRUG

PEG-rASNase

DRUG

Blinatumomab Consolidation in Real World

NCT07117136

B-Cell Acute Lymphoblastic Leukaemia

View study

RECRUITINGPHASE2

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial

NCT06355583

Acute Lymphoblastic LeukaemiaAcute Leukemia of Ambiguous Lineage+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 20, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Blinatumomab Consolidation in Real World

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial

A Multi-center Retrospective Study of INO Treating B-ALL

Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies

Monoclonal Antibodies in Recurrent or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL) (MARALL)

Osteonecroses in Pediatric Patients With ALL