Childhood Acute Lymphoblastic Leukemia, Childhood Lymphoblastic Lymphoma
Conditions
Brief summary
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team * Receiving calaspargase as part of treatment for malignancy
Exclusion criteria
* Age \> 21 years * Patients who are actively enrolled on Children's Oncology Group (COG) trial AALL1732 in an inotuzumab containing arm * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of therapeutic SAA | Up to 15 months | Descriptive statistics including medians and interquartile ranges will be utilized to summarize continuous variables. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORMadeleine B. O'Keefe, MD
Mayo Clinic in Rochester
Outcome results
None listed