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Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 22 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients undergo collection of blood samples and have their medical records reviewed on study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study looks at how calaspargase pegol (Cal-PEG) affects blood clotting. It is for patients ages 2 to 21.5 with acute lymphoblastic leukemia or lymphoma (ALL), cancers of the blood or immune system, who plan to receive Cal-PEG.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 2 to 21.5 years old.
  • Have a confirmed diagnosis of acute lymphoblastic leukemia or lymphoma.
  • Plan to receive Cal-PEG treatment.
  • Have a parent or guardian give informed consent, meaning they understand the study and agree to participation.

Who can't join

  • Already have a blood-clotting disorder.
  • Have a known allergy to asparaginase medicines.
  • Have liver failure.
  • Have a short-term or long-term illness known to affect blood-clotting tests, such as nephrotic syndrome, a kidney condition.
  • Are currently pregnant.
  • Have used a blood thinner that works throughout the body within 48 hours before the study blood draw.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

MN