Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04843514
Other study ID # NOPHO-ALL2008-phamacokinetics
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date January 31, 2024

Study information

Verified date February 2024
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in NOPHO ALL2008 prolonged asparaginase treatment has been implemented. Publish data from NOPHO ALL2008 show sufficient treatment of the majority of patients (analysing trough levels of asparaginase after 2 weeks) but 13% of the patients experience an allergic reaction to this foreign protein (85% of them after the 2nd or 3rd dose) and they have no enzyme activity even before the reaction, meaning that they don't benefit from the treatment at all. In addition 4-5% of the patients have no enzyme activity through the whole treatment without hypersensitivity symptoms. So in reality approximately 20% of the patients don't receive any asparaginase treatment. Therapeutic Drug Monitoring (TDM) of asparaginase has been established in Aarhus, Denmark, under the leadership of Birgitte Klug Albertsen (BKA). From February 2017 the centers have been invited to send samples (extended sampling) in order to gain more knowledge about the pharmacokinetics, to identify patients without activity and to establish the logistics for TDM of asparaginase, which will be mandatory in the next protocol ALLTogether, presumably opening in 2018. From February 2016 an extended sampling for enzyme activity measurements was started and will continue until NOPHO ALL2008 closes. These samples will make it possible to do more in depth pharmacokinetic studies as well as identify the optimal sampling time points for identifying no-activity patients in the future. A database is being developed for TDM in ALLTogether, but it will also include all the asparaginase measurements in ALL2008.


Recruitment information / eligibility

Status Completed
Enrollment 765
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 45 Years
Eligibility Inclusion Criteria: - ALL treated on the NOPHO ALL2008 protocol, age 1-45 years. Exclusion Criteria: - No samples sent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus N
Denmark Aarhus University Hospital, Denmark Aarhus N

Sponsors (1)

Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of the pharmacokinetics after administration of PEG-asparaginase 1000 IU/m2 in NOPHO ALL2008, cohort February 2017 and on 2018-2021
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Recruiting NCT05772000 - Clinical Significance of Occult Central Nervous System Localization
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Active, not recruiting NCT03114865 - A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance Phase 1/Phase 2
Not yet recruiting NCT06308588 - Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Phase 2
Recruiting NCT05579132 - A Phase Ib/II Study of CN201 in Precursor B-cell Acute Lymphoblastic Leukemia Phase 1/Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Terminated NCT02231853 - Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections Phase 1
Recruiting NCT04969601 - Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings Phase 1/Phase 2
Recruiting NCT06195891 - Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome Phase 1
Withdrawn NCT02815059 - Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone Phase 1
Completed NCT00390793 - Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia. Phase 2
Recruiting NCT05866887 - Insomnia Prevention in Children With Acute Lymphoblastic Leukemia N/A
Completed NCT00026780 - Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Not yet recruiting NCT06350994 - Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Withdrawn NCT04282174 - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies Phase 2
Not yet recruiting NCT04488237 - Vitamin D and Methotrexate Adverse Effects
Completed NCT02544438 - Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Phase 1/Phase 2