Recruiting

Calaspargase Pegol

Sponsor:

Mayo Clinic

Code:

NCT07071051

Conditions

Childhood Acute Lymphoblastic Leukemia

Childhood Lymphoblastic Lymphoma

Eligibility Criteria

Sex: All

Age: 2 - 22

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

This study evaluates the impact of calaspargase pegol (Cal-PEG) on the coagulation system in pediatric patients with acute lymphoblastic leukemia/lymphoma (ALL).

Conditions

Childhood Acute Lymphoblastic Leukemia

Childhood Lymphoblastic Lymphoma

Study ID

NCT07071051

Start date

Jul 31, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 22

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 2-21.5 years
  • Confirmed diagnosis of acute lymphoblastic leukemia/lymphoma
  • Planned treatment with Cal-PEG
  • Informed consent obtained from parents or guardians

Exclusion Criteria:

  • Pre-existing coagulation disorders
  • Known hypersensitivity to asparaginase products
  • Liver failure
  • Any acute or chronic disease that is known to affect coagulation testing (e.g. nephrotic syndrome)
  • Currently pregnant
  • Use of systemic blood thinner within 48 hours prior to study blood draw

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients undergo collection of blood samples and have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Change in coagulation - frequency [ Time Frame: Baseline (either before first dose or after at least 6 weeks from last Cal-PEG administration); approximately 4, 11, 18, and 39 days after Cal-PEG administration ]
  • Change in coagulation - duration [ Time Frame: Baseline (either before first dose or after at least 6 weeks from last Cal-PEG administration); approximately 4, 11, 18, and 39 days after Cal-PEG administration ]
  • Incidence of clinically relevant hematologic or thrombotic adverse events [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials

mayocliniccancerstudies@mayo.edu

Principal Investigator:

Madeleine B. O'Keefe, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-13.