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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01251809 |
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Date of registration:
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26/11/2010 |
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Primary sponsor: |
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Public title:
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Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
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Scientific title:
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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 |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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56 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01251809 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Nicola Gökbuget, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitätsklinikum Frankfurt, Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Lymphoblastic Leukaemia
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Intervention(s)
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Drug: Oncaspar
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Drug: PEG-rASNase
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Comparing of treatment arms
[Time Frame: 62 days]
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Secondary ID(s)
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MC-PEGASP.1/adults
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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