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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03267030
Other study ID # NOR-GRASPALL 2016
Secondary ID 2016-004451-70
Status Completed
Phase Phase 2
First received
Last updated
Start date August 23, 2017
Est. completion date October 22, 2020

Study information

Verified date August 2023
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pegylated-asparaginase (PEG-ASP) is an important part of the treatment of childhood acute lymphoblastic leukaemia (ALL). Unfortunately 13% of patients develops allergy and further treatment is impossible. Furthermore, 6% of patients have developed antibodies (silent inactivation) and have no effect of the PEG-ASP treatment. Truncated asparaginase therapy is associated with inferior event-free survival outcomes, in particular relapse in central nervous system (CNS). Eryaspase is a new formulation of asparaginase encapsulated in erythrocytes. The erythrocyte membrane protects asparaginase against fast degradation and elimination processes. The encapsulation eliminates the direct somatic contact, and it is hypothesized that this provides the potential to prolong the activity of the enzyme and reduce toxicities.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date October 22, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 45 Years
Eligibility Inclusion Criteria: 1. Male or female aged 1-45 years at diagnosis of ALL. 2. First line non-high risk ALL patients enrolled in NOPHO ALL2008 or ALLTogether pilot protocols including PEG-ASNase regimen. 3. Documented hypersensitivity reaction to PEG-ASNase with either: Clinical allergy to PEG-ASNase (mild/severe). Serum ASNase activity below the lower level of quantification. 4. Karnofsky/Lansky score =50. 5. Ability to understand and willingness to sign a written ICF and to comply with the scheduled visits, treatment plans, laboratory tests and other study procedures. For patients under 18 years of age, either both parents or the legally appointed representatives had to provide consent. Exclusion Criteria: 1. Philadelphia chromosome positive ALL. 2. Participation in another clinical trial interfering with the study therapy with exception of NOPHO ALL-2008 or ALLTogether pilot protocol. Patients can participate in other clinical trials not interfering with the study drug. In case of doubt this is assessed by the PI. 3. Uncontrolled intercurrent illness including, but not limited to, patients receiving combination antiretroviral therapy or patients with severe or systemic infection, or psychiatric illness/social situations that would limit compliance with study requirements. 4. Other severe acute/chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. 5. Pregnant or lactating females (serum human chorionic gonadotropin pregnancy test at screening). Use of a highly effective contraceptive measure in women of child-bearing potential and sexually active girls that are of child-bearing potential is required (contraceptive measures are specified in section 6.0). 6. Inadequate organ functions, which prohibit further asparaginase administration; 1. History of pancreatitis 2. History of serious hemorrhage or serious thrombosis with prior asparaginase therapy 3. Severe hepatic impairment at the time of administration (bilirubin >3 times ULN, transaminases >10 times ULN) 4. Pre-existing known coagulopathy (e.g. haemophilia) 7. History of grade 3 or higher transfusion reactions or any contraindication to receive blood transfusion. Presence of specific anti-erythrocytes antibodies (auto-antibodies or anti-public antibodies) preventing from getting a compatible packed Red Blood Cells for the patient. 8. Patient under concomitant treatment likely to cause hemolysis.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GRASPA
Administration of 1-7 doses of 150 IU/kg IV infusion. (every 2 weeks for a maximum of 4 doses and every 6 weeks for maximum 3 doses).

Locations

Country Name City State
Denmark Aalborg University Hospital, pediatric department Aalborg
Denmark Aahus University hospial, hematological department Aarhus Aarhus C
Denmark Aarhus University hospital Aarhus Aarhus N
Denmark Rigshospitalet, Child and Adolescent Medicine Copenhagen
Denmark Rigshospitalet, Hematological department Copenhagen
Denmark Odense University hospital, pediatric department Odense
Estonia Tallin Childrens Hospital Tallin
Estonia Tartu University Clinics Tartu
Finland Childrens Hospital, Helsinki. University Central Hospital Helsinki
Finland Kuopio University Hospital Kuopio
Finland University Hospital of Oulu Oulu
Finland Tampere University Hospital Tampere
Finland Turku University Hospital Turku
Lithuania Vilnius University Children's Hospital Vilnius
Norway Helse Bergen Bergen
Norway Oslo Universitetssykehus, Rikshospitalet Oslo
Norway St Olavs Hospital Trondheim
Sweden Drottning Silvias Barn- och ungdomssjukhus Göteborg
Sweden Universitetssjukhuset Linköping Linköping
Sweden Skånes Universitets sjukhus Lund
Sweden Astrid Lindgrens Barnsjukhus Karolinska Stockholm
Sweden arn- och Ungdomscentrum Norrlands Universitetssjukhus Umeå
Sweden Akademiska sjukhuset Uppsala Uppsala

Sponsors (2)

Lead Sponsor Collaborator
Birgitte Klug Albertsen ERYtech Pharma

Countries where clinical trial is conducted

Denmark,  Estonia,  Finland,  Lithuania,  Norway,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics ASNase Activity >100 U/L at 14 Days The primary endpoint was the percentage of patients with ASNase activity >100 U/L at 14 days following the first infusion (nadir). ASNase activity >100 U/L is considered adequate for complete asparagine depletion in the blood. 14 days after first infusion
Secondary Pharmacokinetic Parameters Percentage of patients with ASNase activity >100 U/L at 14 days following the fourth infusion of the 2-week dosing intervals. ASNase activity >100 U/L is considered adequate for complete asparagine depletion in the blood. 14 days after fourth infusion
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