Status:
TERMINATED
Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
Lead Sponsor:
medac GmbH
Conditions:
Acute Lymphoblastic Leukaemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
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 lymph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01251809
Start Date
January 1 2011
End Date
May 1 2013
Last Update
May 20 2013
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité Campus Benjamin Franklin Hämatologie, Onkologie, Transfusionsmedizin Medizinische Klinik III
Berlin, Germany, 12200
2
Charité University Hospital Campus Virchow
Berlin, Germany, 13353
3
Universität Bonn, Medizinische Klinik & Poliklinik III
Bonn, Germany, 53105
4
Städtisches Klinikum Braunschweig Medizinische Klinik III
Braunschweig, Germany, 38114