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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-07667 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 25-009034 | Other Identifier | Mayo Clinic |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients provide blood samples collected during regularly scheduled appointments and have medical records reviewed throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of therapeutic SAA | Descriptive statistics including medians and interquartile ranges will be utilized to summarize continuous variables. | Up to 15 months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team at Mayo Clinic in Rochester
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Madeleine B. O'Keefe, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Up to 15 months |
| 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. | Up to 15 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |