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

Phase 1

Terminated

• Conditions: Acute Lymphoblastic Leukaemia
• Interventions: Drug: PEG-rASNase; Drug: Oncaspar

• Registration Number: NCT01251809
• Lead Sponsor: medac GmbH

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 available

Study Timeline

• Study First Submitted: 2010-11-26
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Study Start: 2011-01
• Primary Completion: 2012-10
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-rASNase 1000	PEG-rASNase	1000 U/m2 BSA at day 0
PEG-rASNase 500	PEG-rASNase	500 U/m2 BSA at day 0
PEG-rASNase 1500	PEG-rASNase	1500 U/m2 at day 0
Oncaspar	Oncaspar	2000 U/m2 at day 0

Primary Outcome Measures

Name	Time	Method
To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.	3 weeks	To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.

Secondary Outcome Measures

Name	Time	Method
Comparing of treatment arms	62 days	the incidence of all other adverse events

Trial Locations

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

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