Forecasting Hypersensitivity Against PEG-asparaginase to Optimize Outcome in ALL

NCT06195735 | Completed

• 1 other identifier: Asp_pharmacokinetic-model
• Study Type: observational
• Target: 649
• Locations: 1 country
• Sites: 1

Brief Summary

Asparaginase is a cornerstone in the treatment of acute lymphoblastic leukemia (ALL). Clinical hypersensitivity reactions and PEG-asparaginase inactivation is common (12-13% of the patients on the NOPHO (Nordic Society for Paediatric Haematology and Oncology) ALL2008 protocol) and has become even more frequent after changing to the current Western European ALL Treatment protocol ALLTogether, despite the PEG coat, leading to increased asparaginase clearance and treatment truncation. Suboptimal anticancer therapy occurs in an additional 3-4% of the patients, who encounter expedited asparaginase clearance but no allergy symptoms (silent inactivation). The aim of this study is to validate and potentially refine an already existing PEG-asparaginase pharmacokinetic model on data from patients treated according to the A2G main protocol.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of participants with hypersensitivity Clinical allergy / silent inactivation

  Patients with allergic reactions or silent inactivation

  2020-2023

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients with ALL 1-45 years of age treated on the ALLTOGETHER main protocol in the Nordic and Baltic countries.

You may qualify if:

• Treated for acute lymphoblastic leukemia (ALL) on the ALLTOGETHER main protocol

You may not qualify if:

• None

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Uppsala University: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Birgitte K Albertsen, M.D.

  Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 323 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor (Pediatric Hematology/Oncology)

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 8, 2024
• Study Start: July 17, 2020
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)