Status:
COMPLETED
Asparaginase Encapsulated in Erythrocytes for Patients With ALL and Hypersensitivity to PEG-asparaginase
Lead Sponsor:
Birgitte Klug Albertsen
Collaborating Sponsors:
ERYtech Pharma
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-45 years
Phase:
PHASE2
Brief 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 impossi...
Eligibility Criteria
Inclusion
- Male or female aged 1-45 years at diagnosis of ALL.
- First line non-high risk ALL patients enrolled in NOPHO ALL2008 or ALLTogether pilot protocols including PEG-ASNase regimen.
- Documented hypersensitivity reaction to PEG-ASNase with either:
- Clinical allergy to PEG-ASNase (mild/severe). Serum ASNase activity below the lower level of quantification.
- Karnofsky/Lansky score ≥50.
- 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
- Philadelphia chromosome positive ALL.
- 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.
- 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.
- 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.
- 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).
- Inadequate organ functions, which prohibit further asparaginase administration;
- History of pancreatitis
- History of serious hemorrhage or serious thrombosis with prior asparaginase therapy
- Severe hepatic impairment at the time of administration (bilirubin \>3 times ULN, transaminases \>10 times ULN)
- Pre-existing known coagulopathy (e.g. haemophilia)
- 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.
- Patient under concomitant treatment likely to cause hemolysis.
Key Trial Info
Start Date :
August 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2020
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03267030
Start Date
August 23 2017
End Date
October 22 2020
Last Update
March 15 2024
Active Locations (23)
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1
Aahus University hospial, hematological department
Aarhus, Aarhus C, Denmark, 8000
2
Aarhus University hospital
Aarhus, Aarhus N, Denmark, 8200
3
Aalborg University Hospital, pediatric department
Aalborg, Denmark
4
Rigshospitalet, Hematological department
Copenhagen, Denmark, 2100