Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 21
SponsorMayo Clinic
About this trial
This study evaluates the median duration of therapeutic serum asparaginase activity (SAA) levels after administration of calaspargase pegol (Cal-PEG) and the potential association between peak SAA levels and duration of therapeutic levels with toxicity in pediatric patients with acute lymphoblastic leukemia or lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team
Receiving calaspargase as part of treatment for malignancy
Disqualifiers
Age > 21 years
Patients who are actively enrolled on Children's Oncology Group (COG) trial AALL1732 in an inotuzumab containing arm
Pregnancy
Trial population
Patients with acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team at Mayo Clinic in Rochester
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
Duration of therapeutic SAA
Descriptive statistics including medians and interquartile ranges will be utilized to summarize continuous variables.
Time frame
Up to 15 monthsOther outcomes
1
Asparaginase-related toxicities correlated with duration of therapeutic SAA levels
Spline plots will be used to assess any correlation between duration of therapeutic SAA levels and incidence of asparaginase-associated toxicities. Categorical data including toxicity information will be summarized descriptively. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, per standard of care.
Time frame
Up to 15 months2
Asparaginase-related toxicities correlated with peak SAA levels
Spline plots will be used to assess any correlation between peak SAA levels and incidence of asparaginase-associated toxicities. Categorical data including toxicity information will be summarized descriptively. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, per standard of care.
Time frame
Up to 15 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: