Clinical trial · Observational
Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration
NCT07221656CI-TRIAL-00107118not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Childhood Lymphoblastic Lymphoma | Childhood Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients provide blood samples collected during regularly scheduled appointments and have medical records reviewed throughout the study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (1)
- measure
- Duration of therapeutic SAA
- timeFrame
- Up to 15 months
- description
- Descriptive statistics including medians and interquartile ranges will be utilized to summarize continuous variables.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.