Status:
COMPLETED
Pharmacokinetics and Immunogenicity of the First Doses of PEG-Asparaginase -An ALLTogether Pilot Study
Lead Sponsor:
Aarhus University Hospital
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-45 years
Brief Summary
Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Survival rates exceed 90% in children and 75% in adults (aged 18-45 years). During the induction period Asparagina...
Detailed Description
Asp enzyme activity is measurable in plasma, and trough levels above 100 IU/l secure effect. Patients, who have their treatment truncated, have inferior outcome. For many years prolonged Asp treatment...
Eligibility Criteria
Inclusion
- Treated for acute lymphoblastic leukemia (ALL) on the ALL2GETHER pilot protocol
Exclusion
- none
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04843150
Start Date
July 1 2020
End Date
October 1 2023
Last Update
February 6 2024
Active Locations (2)
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1
Department of Pediatrics, Skejby Hospital
Aarhus, Denmark, 8200
2
Aarhus University Hospital, Denmark
Aarhus N, Denmark, 8200